Pilot Study to Determine Radioiodide Accumulation and Dosimetry in Breast Cancers Using 124I PET/CT

NCT00725946 | Terminated Early Phase 1

• 4 other identifiers: BRS000198583SU-03142008-1044IRB-11927
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot imaging study for women whose tumors express NIS \[Na+I- symporter, sodium iodide symporter\]. Eligibility is limited to the presence of strong (3+) and/or plasma membrane staining in \> 20% of cells as determined by immunohistochemical methods. A total of 10 patients will be imaged with 124I PET/CT (serial scans over 24 hour period) to determine radioiodide uptake and distribution in tumor tissue. Thyroid iodide uptake and retention will be blocked beginning one week prior to 124I PET/CT scan with thyroid hormone (T3) and methimazole (impedes organification). Tumor, organ and whole body dosimetry will be calculated in each patient.

Conditions

Breast Cancer; Breast Cancer Early Stage Breast Cancer (Stage 1-3); Breast Cancer Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Radioiodide accumulation

  To evaluate radioiodide accumulation in women with immunohistochemically NIS (Na+/I- symporter)-positive breast cancers using 124I PET/CT.

  2 years

Secondary Outcomes (1)

• Dosimetry

  2 years

Study Arms (1)

Iodine-124 PET-CT scan

EXPERIMENTAL

Drug: Iodine-124; Radiation: PET/CT with Iodine-124

Interventions

Iodine-124 DRUG

Iodine-124 PET-CT scan

PET/CT with Iodine-124 RADIATION

Iodine-124 PET-CT scan

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Criteria for NIS-positivity are defined as: \>= 20% of cells with plasma membrane and/or strong intracellular/plasma membrane immunoreactivity 3. Any previous therapy including radiation therapy is allowable. 4. Women 18 years of age or older. 5. Patients must have a life expectancy of at least 3 months 6. Patients with ECOG Performance Status 0-3 will be eligible. 7. If on chemotherapy, thyroid suppression should be initiated no sooner than two weeks after last chemotherapy cycle.
• \. Ability to understand and willingness to sign a written informed consent document.
• \. Discontinuation of hormonal or biological therapies for the 10 days of the study is preferred but not mandated.

You may not qualify if:

• \. Pregnant or nursing patients will be excluded from the study as iodide can accumulate in the breast and is transported across the placenta.
• \. Inability to tolerate thyroid hormone and/or methimazole pre-imaging treatment.
• \. History of thyroid cancer (because patient could have concomitant thyroid cancer metastases and therefore competitively concentrate radioiodides) 6. Psychiatric or addictive disorders that are not adequately controlled and would preclude obtaining informed consent.
• \. Patients with heart disease or other significant cardiac risk factors will be excluded from receiving thyroid suppressive therapy so as to avoid precipitating a cardiac arrhythmia.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Iodine-124

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Irene L. Wapnir

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 9, 2008
• First Posted: July 31, 2008
• Study Start: February 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 11, 2017

Record last verified: 2017-10

Locations

US (1)