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

NCT ID: NCT01360177

Last Updated: 2016-07-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2014-12-31

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.

Conditions

Breast Cancer; Metastatic Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radioactive Iodide and PET/CT

Group Type: EXPERIMENTAL

124 PET/CT imaging

Intervention Type: PROCEDURE

Standard of Care

Na134I

Intervention Type: DRUG

25 to 150 mCi

Tri-iodothyronine

Intervention Type: DRUG

75 ug/8hr x 4 weeks; oral

Tri-iodothyronine

Intervention Type: DRUG

20 mg/day x 2

Interventions

124 PET/CT imaging

Standard of Care

Intervention Type: PROCEDURE

Na134I

25 to 150 mCi

Intervention Type: DRUG

Tri-iodothyronine

75 ug/8hr x 4 weeks; oral

Intervention Type: DRUG

Tri-iodothyronine

20 mg/day x 2

Intervention Type: DRUG

Other Intervention Names

Positron emission tomography - computed tomography; GE Healthcare; T3; T3

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Irene L. Wapnir

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

SU-07292008-1271

Identifier Type: OTHER

Identifier Source: secondary_id

14941

Identifier Type: OTHER

Identifier Source: secondary_id

BRSMTS0012

Identifier Type: -

Identifier Source: org_study_id