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

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.

Study Overview

• Status: Withdrawn
• Conditions: Breast Cancer; Metastatic Breast Cancer
• Intervention / Treatment: Procedure: 124 PET/CT imaging; Drug: Na134I; Drug: Tri-iodothyronine; Drug: Tri-iodothyronine

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Radioactive Iodide and PET/CT	Procedure: 124 PET/CT imaging; Standard of Care; Other Names: Positron emission tomography - computed tomography; Drug: Na134I; 25 to 150 mCi; Other Names: GE Healthcare; Drug: Tri-iodothyronine; 75 ug/8hr x 4 weeks; oral; Other Names: T3; Drug: Tri-iodothyronine; 20 mg/day x 2; Other Names: T3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 WEEKS POST-TREATMENT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	EVALUATED AT 6 WEEKS

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (ANTICIPATED): December 1, 2013
• Study Completion (ANTICIPATED): December 1, 2014

Study Registration Dates

• First Submitted: April 18, 2011
• First Submitted That Met QC Criteria: May 23, 2011
• First Posted (ESTIMATE): May 25, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): July 20, 2016
• Last Update Submitted That Met QC Criteria: July 18, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: BRSMTS0012; SU-07292008-1271 (OTHER: Stanford University); 14941 (Stanford IRB)