[c09aa8]: / clusters / 9knumclustersv2 / clust_2150.txt

Download this file

59 lines (58 with data), 7.9 kB

 1
 2
 3
 4
 5
 6
 7
 8
 9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
History of hypersensitivity to iodine
Progressive, radioactive iodine-refractory, loco-regional recurrent or metastatic disease.
Patients with severe allergic reactions to iodine contrast which cannot be controlled by premedication with antihistamines and steroids.
Allergy to iodine; (NOTE: this does not include reactions to intravenous contrast materials)
Patients unable to follow a low iodine diet or requiring medication with high content in iodide (amiodarone)
Previous failure of iodine- (I) therapy or not candidates to receive I as assessed by treating physician
Patients in which iodine contrast is contraindicated
Allergy to iodine; Note: this does not include reactions to intravenous contrast materials
DTC participants must be iodine-refractory/ relapsed as defined by at least one of the following:
One or more evaluable or measurable lesions that do not demonstrate iodine uptake on any radioiodine scan; or
Cumulative activity of iodine greater than millicuries (mCi) or . gigabecquerels (GBq), with the last dose administered at least months prior to study entry.
Patients unable to follow a low iodine diet or requiring medication with high content in iodide (amiodarone)
Allergy to iodine; this does not include reactions to intravenous contrast materials
Patients with severe allergic reaction to iodine contrast, which cannot be controlled by premedication with antihistamines and steroids (because a hepatic angiogram is needed for the Delcath system procedure).
Unable to follow a low iodine diet or requiring medication with high content in iodide (e.g., amiodarone)
Received iodinated intravenous contrast within =< months of registration; avoidance of iodinated oral contrast is also preferred but not strictly required for study enrollment; NOTE: those who have had iodinated intravenous contrast within this time frame may still be eligible if a urinary iodine analysis reveals that excess iodine has been cleared (defined as urinary iodine documented to be < mcg/day by either a spot urinary iodine or -hour urinary iodine measurement)
No prior systemic therapy or iodine I (I) or chemoembolization treatment after surgery
Prior treatment with therapeutic dose of radioactive iodine (> mCi) with evidence of RAI uptake on delayed scan, with progression within months of RAI
Allergy to iodine\r\n* Note: This does not include reactions to intravenous contrast materials
Dose Escalation cohort only: Allergy to iodine; NOTE: this does not include reactions to intravenous contrast materials
The tumor is considered to be radioactive-iodine refractory by any of the following criteria:\r\n* Total lifetime dose of radioactive iodine > mCi\r\n* Absent or insufficient radioactive iodine uptake in either all lesions or an index lesion which has never been resected or received external beam radiation therapy as documented on a radioactive iodine scan (insufficient uptake must be confirmed by either an endocrinologist or nuclear medicine physician)\r\n* Progression of disease (by imaging or thyroglobulin) within months of radioactive iodine treatment\r\n* Fludeoxyglucose F (FDG)-avid lesion (standard uptake variable maximum [SUVmax] >= ) on a FDG-positron emission tomography (PET) scan
No recent treatment for thyroid cancer as defined as:\r\n* No radioactive iodine therapy is allowed if given < months prior to initiation of this protocol therapy; a diagnostic study using < mCi of radioactive iodine (RAI) is not considered radioactive iodine therapy\r\n* No external beam radiation therapy < weeks prior to initiation of therapy on this protocol\r\n* No chemotherapy or targeted therapy (e.g., tyrosine kinase inhibitor) is allowed < weeks prior to the initiation of therapy
Willingness to maintain a low iodine diet for days (starting days prior to virus injection continuing until after the I radioiodine therapy on Day )
Goggle assessment substudy: iodine or seafood allergies
Patients unable to follow a low iodine diet or requiring medication with high content in iodide (amiodarone)
Patients in whom iodine contrast is contraindicated
An allergy to iodine
Patients who have been treated with radioactive iodine within weeks prior to study enrollment (radioactive iodine within weeks will be allowed if negative post-treatment scan or progressive disease defined by RECIST .)
Patient must have radioiodine refractory disease as defined by one or more of the following conditions:\r\n* All cases of medullary thyroid carcinoma\r\n* No iodine-uptake on a post-radioactive iodine treatment scan (in presence of low iodine diet and thyroid stimulating hormone [TSH] suppression) in an anatomically defined lesion that qualifies as target lesion by RECIST criteria, OR\r\n* If there is demonstrable iodine-uptake: the last radioiodine therapy of (>= mCi) was given within the last months OR if given more than months before enrollment, there is evidence of disease progression after each of the last two radioiodine treatment performed within months of each other (each dose should be >= mCi), OR\r\n* If the patient has received the maximum cumulative life time dose of radioactive iodine treatments of at least mCi\r\n* If the patient declines or is intolerant of radioiodine therapy or if with progressive disease that is, in the opinion of the treating physician, likely to benefit from biologic therapy rather than further iodine therapy e.g. patient with heavy burden of disease
Within months of enrollment, patients must have had a radioactive iodine (RAI) scan, showing no or therapeutically insignificant RAI uptake (=< %)
Subject has a known history contraindicating contrast dye or iodine that cannot be safely controlled via antihistamine, steroids, or with any other agent.
Has known allergy or history of adverse reaction to ICG, iodine or iodine dyes.
History of iodine hypersensitivity
Patients in which iodine contrast is contraindicated
Known allergy or history of adverse reaction to ICG, iodine or iodine dyes.
Patients must have previously received standard systemic therapy for advanced thyroid cancer (to include radioactive iodine for iodine-avid tumors and surgery [if indicated]) and have been either non-responders (progressive disease) or have recurred
Subjects who are pregnant or may become pregnant during metformin administration in accordance with radioactive iodine treatment guidelines
Women with dialysis, chronic urinary infection, hyperthyroidism, current infection, or a history of allergy or sensitivity to iodine will not be eligible to participate
Patients with a history of skin allergy to iodine or adhesive drapes
Women with a known allergy to proflavine, acriflavine, or iodine
Known prior allergic reaction to ICG or allergy to iodine
Patients unable to follow a low iodine diet or requiring medication with high content in iodide (amiodarone)
Women with iodine contrast allergy
Known allergy to iodine or intravenous contrast agent.
Allergic reaction to iodine-containing contrast material
History of allergy to iodine
Previous or on-going radioactive iodine treatment.
The patient has known or suspected allergies to iodine, indocyanine green (ICG) or isosulfan blue (ISB)
history of hypersensitivity to iodine
Iodine allergy, hyperthyroidism, or Graves disease
Contraindication for oral potassium iodine administration
The patient has a documented intravenous contrast allergy or iodine allergy
History of iodine hypersensitivity
Participants with a known or suspected allergy to iodine
History of hypersensitivity to iodine.
Participants must be Iodine- refractory/resistant as defined by at least one of the following:
One or more measurable lesions that do not demonstrate iodine uptake on any radioiodine scan.
Cumulative activity of Iodine- of > mCi or gigabecquerels (GBq), with the last dose administered at least months prior to study entry.