Pregnancy. If a woman has been confirmed as pregnant she will not be eligible to take part in the trial. If she suspects there is a chance that she may be pregnant, a pregnancy test should be undertaken; however, a pregnancy test for all women of child-bearing potential is not mandatory
Women who are breastfeeding or pregnant as evidenced by a positive pregnancy test within 14 days of first dose.
Pregnancy tests for females of childbearing potential are required; must be serum at screening and the post treatment safety assessment visit; a positive urine pregnancy test must be confirmed by a serum pregnancy test and a pelvic ultrasound (US); a pelvic US does not need to be repeated with each cycle unless the treating physician thinks it is necessary to do so
Pregnancy or expressed plans to become pregnant within 1 year of the procedure
Women of child-bearing age must obtain a pregnancy test and pregnant or breast-feeding females are excluded
Pregnant or lactating, or intending to become pregnant during the study\r\n* Women of childbearing potential must have a negative serum pregnancy test result within 21 days prior to initiation of study drug
Males and females of reproductive potential who are not using and effective method of birth control and females who are pregnant or breastfeeding or have a positive (urine or serum) pregnancy test prior to study entry
Is lactating or pregnant as confirmed by pregnancy tests performed within 7 days before enrollment
Pregnant patients do not meet inclusion criteria for radiation therapy.\r\n* Patients who subsequently become pregnant may continue follow up within the protocol, but a negative urine pregnancy test will need to be obtained before additional lesions may be enrolled.
Patients who are pregnant or lactating, plan to get pregnant, or have a positive serum pregnancy test prior to randomization.
Pregnant women; if patients are not status post bilateral salpingo-oopherectomy then pregnancy testing is required
Pregnant or need to breast feed during the study period (negative serum pregnancy test required)
Pregnant or breast-feeding. (While pregnancy is unlikely in view of the disease and previous surgery, subjects whom the investigator considers may be at risk of pregnancy will have a pregnancy [beta-HCG] test and will be using a medically approved contraceptive method).
Sex and reproductive status; a) women of childbearing potential (WOCBP) who are pregnant or breastfeeding; b) women with a positive pregnancy test at enrollment or prior to administration of study medication
Women who are pregnant or breast feeding; a pregnancy test will be administered to women of child bearing potential (per institutional policies) at screening; women must agree to pregnancy tests prior to (up to 1 calendar day) each administration of a radionuclidic agent, including tracer doses, to be considered for this study
Pregnancy status will be obtained at time of consent as is routine for all radiation patients; pregnant women are excluded from this study
Pregnancy or breastfeeding; a pregnancy test must be performed within 7 days prior to ibrutinib initiation in women of childbearing potential; pregnant women; breastfeeding must be discontinued because of unknown but potential risks in the nursing infant
Is pregnant (confirmed by positive serum pregnancy test) or lactating
Pregnant or breast feeding; the agents used in this study include pregnancy category D: known to cause harm to a fetus; females of childbearing potential must have a negative pregnancy test prior to starting therapy
Pregnant or breast feeding women are excluded from participating in this study; WOCBP must have a negative serum pregnancy test within 7 days of the first administration of decitabine
Female patients who are lactating or have a positive serum pregnancy test suggestive of pregnancy and not as a tumor marker during the screening period; if pregnancy is tested positive, treating physician will further investigate if the patient is pregnant or not; treating physician may consider repeating the serum beta-hCG at next follow up visit or refer patient to obstetrical/gynecological (OB/GYN) for further evaluation
Women who are breast-feeding or pregnant as evidenced by positive urine pregnancy test done within 72 hours of first dosing
Women must not be pregnant or breast-feeding\r\n* All female patients of child-bearing potential must have a negative serum pregnancy test within 2 weeks prior to treatment to rule out pregnancy \r\n* Pregnancy testing is not required for post-menopausal or surgically sterilized women
Not pregnant or breastfeeding; a negative pregnancy test is required within 14 days of registration for pre- or perimenopausal (i.e., last menstrual period within one year of registration) women
Women who are pregnant, which includes women with a positive pregnancy test at enrollment or prior to the administration of study medication, or breastfeeding are not allowed on study
Women who are not postmenopausal or have not undergone hysterectomy must have a documented negative serum pregnancy test per standard MCC-VCUHS BMT Program guidelines
Report of pregnancy, attempting to get pregnant, or actively breast feeding or positive urine pregnancy test (only given to females with child bearing potential)
Pregnant females are excluded; women of childbearing age/menstruating must confirm they are not sexually active or have a negative pregnancy test prior to initiation of radiation therapy
Pregnant women and women who are breast feeding are excluded; negative pregnancy test is required for all women of child-bearing age, and appropriate contraception is used during the study period; pregnancy testing will be carried out within two weeks prior to administration of radioiodinated 8H9 in females of childbearing age
Pregnant or breastfeeding - The agents used in this study fall under Pregnancy Category D - Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. Women of childbearing potential must have a negative pregnancy test (urine or serum) within 7 days of study drug administration
The subject is pregnant, as defined by a presumptive sign of pregnancy such as missed menses or a positive pregnancy test
Pregnant or lactating women; patients in reproductive age must agree to use contraceptive methods for the duration of the study (a pregnancy test will be obtained before treatment)
Pregnancy: All subjects will have a beta-human chorionic gonadotropin (hCG) serum pregnancy test to rule out pregnancy, a history will also be taken to make certain that recent sexual exposure does not put them at risk for pregnancy; if so a second serum pregnancy test will be done; volunteers will be asked to use barrier contraception during study
Females who are pregnant, breastfeeding or who have a positive pregnancy test at screening or Day 1
Women who are pregnant or breast feeding; women with a positive pregnancy test on enrollment or prior to study drug administration
Females who are pregnant, breastfeeding or who have a positive pregnancy test at screening or Day 1.
Pregnant or lactating females; serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days (with a confirmatory urine pregnancy test within 7 days prior to study treatment start)
Women who are breastfeeding or pregnant as evidenced by positive serum pregnancy test
Women who are pregnant (including positive pregnancy test at enrollment or prior to study drug administration) or breast-feeding
Women who are breastfeeding or pregnant as evidenced by positive serum pregnancy test
Pregnant or lactating, or intending to become pregnant during the study: Women who are not postmenopausal (>=12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of study drug
Women who are breast feeding or pregnant as evidenced by positive serum pregnancy test.
Negative serum or urine pregnancy test; the pregnancy test result must be obtained prior to the first administration of AUY922 (=< 14 days prior to dosing) in all pre-menopausal women and women < 2 years after the onset of menopause
Pregnant females are excluded; women of childbearing age/menstruating must confirm that they are not sexually active or have a negative pregnancy test prior to initiation of radiation therapy
Patients must not be pregnant (positive pregnancy test) or breast feeding; pregnancy test must be done within 7 days prior to registration; effective contraception (men and women) must be used in patients of child-bearing potential while on study treatment and for 6 months after
Female research participants >= 10 years of age or post-menarchal must not be pregnant (confirmed by serum or urine pregnancy test within 1 week of study enrollment) or breastfeeding
Females of childbearing potential (a female not post-menopausal for at least 12 months or not surgically sterilized) must have a negative beta-human chorionic gonadotropin (HCG) pregnancy =< 7 days prior to day 1 of cycle 1; if the pregnancy test is outside institutional normal range at pretreatment, the subject must have a second pregnancy test; if the second pregnancy test is outside institutional normal range then a gynecology consult is needed to confirm the subject is not pregnant; all patients must agree to use an effective contraceptive method during the course of the study
Patients who are pregnant (positive pregnancy test) or nursing. Use of effective means of contraception (men and women) in subjects of child-bearing potential. To date, no fetal studies in animals or humans have been performed. The possibility of harm to a fetus is likely. Bevacizumab specifically inhibits VEGF, which is responsible for formation of new blood vessels during development, and antibodies can cross the placenta. Therefore, bevacizumab should not be administered to pregnant women.
Pregnant females are excluded; women of childbearing age/menstruating must confirm that they are not sexually active or have a negative pregnancy test prior to initiation of radiation therapy
Premenopausal and postmenopausal (amenorrheic for less than 12 months) women with either a positive or no pregnancy test (serum or urine) at baseline within 7 days study enrollment; postmenopausal women who are amenorrheic for more than 12 months do not require pregnancy test
Women who are pregnant (including positive pregnancy test at enrollment or prior to study drug administration) or breastfeeding
Women who are pregnant (confirmed by positive pregnancy test) or lactating
Pregnant or breast feeding females (a urine pregnancy test will be obtained in all women of child-bearing age at initial screening prior to study enrollment and administration of chemotherapy)
Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to enrollment; if urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\r\n* If a pregnancy occurs, the study doctor must be notified; the study doctor should notify the study sponsor as well as Amgen of the pregnancy, discuss any follow-up with the subject (and/or his partner), and ask for information on the pregnancy outcome; the patient should be asked if she wishes to consent to follow up through the Amgen pregnancy surveillance program\r\n* If the female partner is already pregnant when the male subject begins treatment with talimogene laherparepvec, he must refrain from any sort of sexual activity that could expose his partner or the unborn baby to talimogene laherparepvec through semen, or wear a latex condom during sexual activity while receiving treatment with talimogene laherparepvec and for at least 3 months after the last talimogene laherparepvec administration
Women who are pregnant or nursing (pregnancy test to be performed within 24 hours prior to HIFU treatment)
Women who are pregnant or nursing (pregnancy test to be performed within 24 hours prior to HIFU treatment)
Pregnancy or breastfeeding - menstruating females must have a negative pregnancy test prior to study enrollment and agree to repeat pregnancy testing and contraception use per protocol
Pregnancy confirmed by pregnancy test / Lactating women;
Females who are pregnant, lactating, or intend to become pregnant during the participation of the study; childbearing age women who are not on birth control; positive pregnancy test for women of childbearing potential, as defined by intact uterus and ovaries, and no history of menses within the last 12 months; pregnancy test to be performed on the day of enrollment; in cases of women with elevated beta-human chorionic gonadotropin (b-HCG), these candidates will be eligible to participate so long as the level of b-HCG is not consistent with pregnancy and the non-pregnant status is confirmed by a gynecologic examination
Pregnant women will also be excluded (Phase I, part B and Phase II); all female participants who are pregnant or become pregnant over the course of the study are not eligible to participate; women of childbearing potential will be asked to complete a blood pregnancy test (using 1 teaspoon of blood drawn from a vein by needle stick) at their first study visit, and the test must be negative before the woman can continue in the study; women of childbearing potential will be asked to agree to use appropriate contraceptive measures for the duration of the study; participants with medically verified menopausal status (e.g., via tests of ovarian functioning documented in the participants’ medical record) will not be asked to complete a blood pregnancy test
Currently pregnant (assessed by serum pregnancy test)
Women who are pregnant at time of enrollment; pregnancy will be assessed at enrollment using urine pregnancy test
Women will be excluded if they intend to become or are pregnant or lactating; men and women will be required to take active measures to prevent pregnancy while on the study
All pre-menopausal women will require a urine qualitative pregnancy test to exclude pregnancy; pregnant women will be excluded from the study
Not pregnant (confirmed by a pregnancy test)
Women who self-report to be pregnant\r\n* As this is an observational study, we will not be performing a pregnancy test, participants will be asked if they are or are not pregnant
Pregnant or breastfeeding women; positive pregnancy test within 7 days of starting treatment
Patients who are pregnant or breastfeeding; patients will be asked about the possibility of pregnancy; a pregnancy test will be obtained for those patients who have been sexually active without using birth control since their last menstrual period; pregnancy status can be confirmed using any of the following: pregnancy test, prior hysterectomy, tubal ligation, use of intra-uterine device (IUD) or Depo-Provera, or if the woman is beyond childbearing age
Women who are pregnant or nursing; pregnancy will be confirmed by urine test
Patients who are known to be pregnant or who are breastfeeding; patients will be asked about pregnancy status and a pregnancy test will be performed only if there is a high probability of pregnancy
Women who are pregnant or plan a pregnancy within 8 weeks after completion of treatment (only for patients who are going to be randomized to either therapeutic arms)
Subject is pregnant (documented by a positive pregnancy test according to hospital standard practices) or is actively breast-feeding.
Currently pregnant or within 3 months post-partum, or unwilling to undergo pregnancy testing or report possible pregnancy promptly
Pregnant women are excluded from this study because CESM uses radiation with the potential for teratogenic or abortifacient effects. This will be defined by a urine pregnancy test prior to the CESM study.
Women who are pregnant or post-partum (within 3 months of delivery); patients are deemed not pregnant by virtue of urine pregnancy test (UPT), transvaginal ultrasound, beta human chorionic gonadotropin (HCG), or best judgement of the investigator; pregnancy testing is not required per protocol to determine study eligibility; women who become pregnant on the ISDO arm via reproductive technology can remain on study; however, data collection will be suspended during pregnancy and 3 months post-partum
Women who are able to become pregnant must have a confirmed negative pregnancy test result prior to enrollment; women >= 50 years of age who have not had a menstrual period in the past year; and women who have had a hysterectomy, both ovaries removed, or a tubal ligation; will not be required to have a pregnancy test
Women who are able to become pregnant must have a confirmed negative pregnancy test result prior to enrollment; women who are >= 60 years old or who have had a hysterectomy, both ovaries removed, or a tubal ligation will not be required to have a pregnancy test
Pregnancy at any point during the study period OR considering pregnancy during the study period
Women on study must be neither pregnant nor nursing nor expected to become pregnant during therapy; for premenopausal women, negative pregnancy test within 14 days of RT is required
The patient is pregnant as confirmed by urine or serum pregnancy testing,
Patients who are pregnant or lactating or who suspect they might be pregnant; serum pregnancy tests will be obtained prior to each set of multi-tracer PET scans in female patients that are not postmenopausal or surgically sterile
Pregnant or lactating women: pregnant women are excluded from this study because the effects of [18F] FAZA in pregnancy are not known. A urine or serum pregnancy test will be performed before accrual after informed consent is obtained.
Pregnant women or breastfeeding\r\n* Potential subjects will be asked if they are pregnant; verbal confirmation of pregnancy will be sufficient
Patients who are currently pregnant or breast feeding; a pregnancy test within 72 hours of the first PET/MRI will be performed
Breastfeeding women or females of childbearing potential with a positive pregnancy test prior to the procedure or the intent to become pregnant during the study.
Pregnancy; regular clinical practice already excludes pregnant patients from gadolinium contrast; the current clinical practice will be applied - patients will be verbally screened and asked if they think they could be pregnant; if the answer is yes, then the patient will be excluded from the study; if the patient is uncertain about the pregnancy status, she will be given an option to undergo a pregnancy test or not participate in the study altogether; patients who self-report that they are not pregnant will be allowed to participate in the study; this procedure is based on current department policy guidelines
Patients who are pregnant or lactating or who suspect they might be pregnant are not eligible; a serum pregnancy tests will be obtained 24-48 hours prior to the initial PET scan in female patients who are not postmenopausal or surgically sterile
Patients who are pregnant or lactating or who suspect they might be pregnant; serum pregnancy tests will be obtained prior to each set of multi-tracer PET scans in female patients that are not postmenopausal or surgically sterile
Women who are pregnant, as well as those women who are breastfeeding, will be excluded from this study; as part of their routine preoperative testing, all women of child bearing age receive a pregnancy test; the research staff will follow up on these results in order to determine eligibility; women who have had a hysterectomy or have not had menses for > 24 months will not be required to undergo a pregnancy test; breastfeeding women will be excluded from this study
Pregnant or lactating; women of childbearing potential with either a positive or no pregnancy test at baseline are excluded
Patients who are pregnant or lactating or who suspect they might be pregnant; serum pregnancy tests will be obtained prior to the baseline and subsequent multi-tracer PET scans in female patients that are not postmenopausal or surgically sterile
Pregnant or lactating female, a serum pregnancy test will be performed within 2 weeks or less before the date of the FCH PET/CT scan in all women capable of becoming pregnant
Females who are pregnant as confirmed by a positive serum or urine pregnancy test or are breastfeeding.
Breastfeeding or pregnant; serum pregnancy test will be conducted
Patients who are pregnant or lactating or who suspect they might be pregnant; serum pregnancy tests will be obtained prior to the baseline and subsequent multi-tracer PET scans in female patients that are not postmenopausal or surgically sterile
Female patients undergoing optional 18F-MISO-PET scan cannot be pregnant or nursing, as confirmed by serum pregnancy test if the patient is a woman of child-bearing potential; females of child-bearing potential are defined according to Food and Drug Administration (FDA) guidelines as women capable of becoming pregnant, including women on oral injectable or mechanical contraception, women who are single, women whose husbands have been vasectomized, or women whose husbands have received or are utilizing mechanical contraceptive devices; if the result of the pregnancy test is positive, the patient (female) will be withdrawn from the study prior to administration of study treatment
Pregnant or breastfeeding - if the subject is female, the investigator will provide a urine pregnancy test at no cost to the subject; the subject will take the pregnancy test immediately before participating in this study
Women who are pregnant or lactating, if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus