Back to resultsRadioactive Iodide (131I) Treatment of 124I PET/CT Detected Breast Cancers
Primary Purpose
Breast Cancer, Metastatic Breast Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
124 PET/CT imaging
Na134I
Tri-iodothyronine
Tri-iodothyronine
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients with measurable locally advanced or metastatic breast cancer who completed 124I PET/CT imaging study.
- Patients who are 18 years of age or older.
- Patients must have a life expectancy of at least 3 months.
- I 124 dosimetry completed with thyroid dose to 500 cGy or less and tumor dose of 2500 cGy or more.
- I131 therapeutic dose calculated from dosimetry. Dose must be in a range of 25 to 150 mCi.
- Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3 will be eligible.
- Use of concurrent systemic therapy (hormonal or cytotoxic) if associated with stable disease for at least three months prior to treatment.
- Women with locally advanced breast cancer and simultaneous metastases, even if surgery to eradicate local disease has taken place.
- Thyroid stimulating hormone (TSH) must be < 0.4 uIU/mL.
- White blood cell count >= 1,500 and platelet count >= 40,000
- Women receiving thyroid hormone supplements and methimazole.
- Ability to understand and the willingness to sign a written informed consent document.
- Premenopausal women must use contraception while receiving this treatment and during follow-up period of 42 days.
Exclusion Criteria:
- Stage 0-II breast cancer.
- Pregnant or nursing women.
- Not able to sign informed consent.
- Untreated psychiatric disorder.
- Women who have not had I124 PET/CT scan and dosimetry calculations.
- Radioiodide uptake in non-target organs or bone marrow does not exceed 25 cGy by pre-treatment dosimetry.
- Received chemotherapy less than 4 weeks before.
- History of thyroid cancer.
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Radioactive Iodide and PET/CT
Arm Description
Outcomes
Primary Outcome Measures
Target lesion size will be assessed clinically or radiologically in two directions . RECIST (Response Evaluation Criteria In Solid Tumors) will be implemented to determine response
cCR (complete clinical response) = disappearance of all tumor
cPR (clinical partial response) = >=30% decrease sum of longest target lesion diameters
cPD (progressive disease) = >=20% increase sum of longest target lesion diameters.
cSD (stable disease) = small changes that do not meet these criteria
Secondary Outcome Measures
Non target lesion size will be assessed clinically or radiologically in two directions . RECIST (Response Evaluation Criteria In Solid Tumors) will be implemented to determine response
Complete Response (CR): Disappearance of all non-target lesions
Incomplete Response/Stable Disease (SD): Persistence of one or more non-target lesions(s)
Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01360177
Brief Title
Radioactive Iodide (131I) Treatment of 124I PET/CT Detected Breast Cancers
Official Title
Radioactive Iodide (131I) Treatment of 124I PET/CT Detected Breast Cancers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Withdrawn
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a treatment protocol designed to accompany the ongoing institutional 124I PET/CT pilot imaging study for patients with invasive breast cancer. Women whose tumors express NIS [Na+I- symporter, sodium iodide symporter] and demonstrate radioiodide uptake on 124I PET/CT scans will be eligible for 131I treatment if, (1) tumor dosimetry calculations yield a cumulative radiation dose of at least 30Gy in target tumor, (2) estimated cumulative thyroid irradiation is less than 500 cGy and, (3) the therapeutic dose of 131I is in the range of 25 to 100 mCi.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Metastatic Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radioactive Iodide and PET/CT
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
124 PET/CT imaging
Other Intervention Name(s)
Positron emission tomography - computed tomography
Intervention Description
Standard of Care
Intervention Type
Drug
Intervention Name(s)
Na134I
Other Intervention Name(s)
GE Healthcare
Intervention Description
25 to 150 mCi
Intervention Type
Drug
Intervention Name(s)
Tri-iodothyronine
Other Intervention Name(s)
T3
Intervention Description
75 ug/8hr x 4 weeks; oral
Intervention Type
Drug
Intervention Name(s)
Tri-iodothyronine
Other Intervention Name(s)
T3
Intervention Description
20 mg/day x 2
Primary Outcome Measure Information:
Title
Target lesion size will be assessed clinically or radiologically in two directions . RECIST (Response Evaluation Criteria In Solid Tumors) will be implemented to determine response
Description
cCR (complete clinical response) = disappearance of all tumor
cPR (clinical partial response) = >=30% decrease sum of longest target lesion diameters
cPD (progressive disease) = >=20% increase sum of longest target lesion diameters.
cSD (stable disease) = small changes that do not meet these criteria
Time Frame
6 WEEKS POST-TREATMENT
Secondary Outcome Measure Information:
Title
Non target lesion size will be assessed clinically or radiologically in two directions . RECIST (Response Evaluation Criteria In Solid Tumors) will be implemented to determine response
Description
Complete Response (CR): Disappearance of all non-target lesions
Incomplete Response/Stable Disease (SD): Persistence of one or more non-target lesions(s)
Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time Frame
EVALUATED AT 6 WEEKS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with measurable locally advanced or metastatic breast cancer who completed 124I PET/CT imaging study.
Patients who are 18 years of age or older.
Patients must have a life expectancy of at least 3 months.
I 124 dosimetry completed with thyroid dose to 500 cGy or less and tumor dose of 2500 cGy or more.
I131 therapeutic dose calculated from dosimetry. Dose must be in a range of 25 to 150 mCi.
Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3 will be eligible.
Use of concurrent systemic therapy (hormonal or cytotoxic) if associated with stable disease for at least three months prior to treatment.
Women with locally advanced breast cancer and simultaneous metastases, even if surgery to eradicate local disease has taken place.
Thyroid stimulating hormone (TSH) must be < 0.4 uIU/mL.
White blood cell count >= 1,500 and platelet count >= 40,000
Women receiving thyroid hormone supplements and methimazole.
Ability to understand and the willingness to sign a written informed consent document.
Premenopausal women must use contraception while receiving this treatment and during follow-up period of 42 days.
Exclusion Criteria:
Stage 0-II breast cancer.
Pregnant or nursing women.
Not able to sign informed consent.
Untreated psychiatric disorder.
Women who have not had I124 PET/CT scan and dosimetry calculations.
Radioiodide uptake in non-target organs or bone marrow does not exceed 25 cGy by pre-treatment dosimetry.
Received chemotherapy less than 4 weeks before.
History of thyroid cancer.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irene L. Wapnir
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Radioactive Iodide (131I) Treatment of 124I PET/CT Detected Breast Cancers
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