Radioactive Iodide (131I) Treatment of 124I PET/CT Detected Breast Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01360177
Recruitment Status : Withdrawn
First Posted : May 25, 2011
Last Update Posted : July 20, 2016
Information provided by (Responsible Party):
Stanford University

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Metastatic Breast Cancer Procedure: 124 PET/CT imaging Drug: Na134I Drug: Tri-iodothyronine Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radioactive Iodide (131I) Treatment of 124I PET/CT Detected Breast Cancers
Study Start Date : July 2010
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Iodine

Arm Intervention/treatment
Experimental: Radioactive Iodide and PET/CT Procedure: 124 PET/CT imaging
Standard of Care
Other Name: Positron emission tomography - computed tomography

Drug: Na134I
25 to 150 mCi
Other Name: GE Healthcare

Drug: Tri-iodothyronine
75 ug/8hr x 4 weeks; oral
Other Name: T3

Drug: Tri-iodothyronine
20 mg/day x 2
Other Name: T3

Primary Outcome Measures :
  1. 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 [ Time Frame: 6 WEEKS POST-TREATMENT ]
    • 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 :
  1. 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 [ Time Frame: EVALUATED AT 6 WEEKS ]
    • 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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01360177

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Principal Investigator: Irene L. Wapnir Stanford University

Responsible Party: Stanford University Identifier: NCT01360177     History of Changes
Other Study ID Numbers: BRSMTS0012
SU-07292008-1271 ( Other Identifier: Stanford University )
14941 ( Other Identifier: Stanford IRB )
First Posted: May 25, 2011    Key Record Dates
Last Update Posted: July 20, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Growth Substances
Physiological Effects of Drugs