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

• ClinicalTrials.gov Identifier: NCT00725946
• Recruitment Status: Terminated
• First Posted: July 31, 2008
• Last Update Posted: October 11, 2017
• Sponsor: Stanford University
• Information provided by (Responsible Party): Irene L. Wapnir, Stanford University

Tracking Information

• First Submitted Date: July 9, 2008
• First Posted Date: July 31, 2008
• Last Update Posted Date: October 11, 2017
• Study Start Date: February 2008
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 5, 2012)

Radioiodide accumulation [ Time Frame: 2 years ]

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

• Original Primary Outcome Measures (submitted: July 30, 2008): To determine whether radioiodide accumulation is detectable and congruent with tumor distribution on 124I PET/CT in NIS-expressing breast cancers.

Current Secondary Outcome Measures (submitted: December 5, 2012)

Dosimetry [ Time Frame: 2 years ]

To calculate dosimetry in tumor, thyroid and whole body.

• Original Secondary Outcome Measures (submitted: July 30, 2008): To calculate tumor, organ and whole body dosimetry under thyroid suppressive conditions.
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pilot Study to Determine Radioiodide Accumulation and Dosimetry in Breast Cancers Using 124I PET/CT
• Official Title: A Pilot Study to Determine Radioiodide Accumulation and Dosimetry in Breast Cancers Using 124I PET/CT
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Early Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic

Condition

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

Intervention

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

Study Arms

Experimental: Iodine-124 PET-CT scan

Interventions:

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: May 30, 2013): 7
• Original Enrollment (submitted: July 30, 2008): 10
• Actual Study Completion Date: December 2012
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:1. Stage I-IV breast cancer. Patients must have clinical or radiographic evidence of localized or metastatic disease.

2. 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.

8. Ability to understand and willingness to sign a written informed consent document.

9. Discontinuation of hormonal or biological therapies for the 10 days of the study is preferred but not mandated.

10. Laboratory tests (CBC, comprehensive metabolic panel) must be performed within 120 day prior to study initiation. Exclusion Criteria:1. History of metastatic thyroid cancer 2. Exclude the use of cytotoxic, hormonal or biological agents for one week prior to and during imaging.

3. Pregnant or nursing patients will be excluded from the study as iodide can accumulate in the breast and is transported across the placenta.

4. Inability to tolerate thyroid hormone and/or methimazole pre-imaging treatment.

5. 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.

7. 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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00725946
• Other Study ID Numbers: BRS0001; 98583 ( Other Identifier: Stanford University Alternate IRB Approval Number ); SU-03142008-1044 ( Other Identifier: Stanford University ); IRB-11927 ( Other Identifier: Stanford Universtiy )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Irene L. Wapnir, Stanford University
• Original Responsible Party: Not Provided
• Current Study Sponsor: Stanford University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Irene L. Wapnir; Stanford University

• PRS Account: Stanford University
• Verification Date: October 2017