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

NCT01360177 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2016-07-20

No results posted yet for this study

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

Interventions

PROCEDURE

124 PET/CT imaging

Standard of Care

DRUG

Na134I

25 to 150 mCi

DRUG

Tri-iodothyronine

75 ug/8hr x 4 weeks; oral

DRUG

Tri-iodothyronine

20 mg/day x 2

Sponsors & Collaborators

Principal Investigators

  • Irene L. Wapnir · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2013-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01360177 on ClinicalTrials.gov