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

July 18, 2016 updated by: Stanford University
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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: 6 WEEKS POST-TREATMENT
  • 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: EVALUATED AT 6 WEEKS
  • 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2010

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2013

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 25, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BRSMTS0012
  • SU-07292008-1271 (OTHER: Stanford University)
  • 14941 (Stanford IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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