Breast CancerNCT01360177
Radioactive Iodide (131I) Treatment of 124I PET/CT Detected Breast Cancers
A study testing 124 PET/CT imaging, Na134I and Tri-iodothyronine in people with Breast Cancer and Metastatic Breast Cancer, run by Stanford University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Metastatic Breast Cancer
- What is being tested?
- 124 PET/CT imaging, Na134I and Tri-iodothyronine
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 13Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
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
- Breast Cancer, Metastatic Breast Cancer
- Being tested
- 124 PET/CT imaging, Na134I, Tri-iodothyronine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
124 PET/CT imagingProcedure or surgery
Also called Positron emission tomography - computed tomography
Standard of Care
Na134IDrug
Also called GE Healthcare
25 to 150 mCi
Tri-iodothyronineDrug
Also called T3
75 ug/8hr x 4 weeks; oral
Tri-iodothyronineDrug
Also called T3
20 mg/day x 2
| Study group | Role | What they receive |
|---|---|---|
| Radioactive Iodide and PET/CT | Experimental | Not described Receives: Procedure: 124 PET/CT imaging; Drug: Na134I; Drug: Tri-iodothyronine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 WEEKS POST-TREATMENT
Secondary outcomes (1)
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
Measured: EVALUATED AT 6 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study startJul 2010
- Primary completionDec 2013 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irene L. Wapnir, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01360177
- Sponsor's protocol ID
- BRSMTS0012
- Other IDs
- SU-07292008-1271, 14941
- Status last verified
- Jul 2016
- First submitted
- 18 Apr 2011
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radioactive Iodide (131I) Treatment of 124I PET/CT Detected Breast Cancers
- ClinicalTrials.gov ID
- NCT01360177
- Acronym / sponsor ID
- BRSMTS0012
- Conditions
- Breast Cancer, Metastatic Breast Cancer
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 25 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radioactive Iodide and PET/CT | Experimental | Procedure: 124 PET/CT imaging, Drug: Na134I, Drug: Tri-iodothyronine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 124 PET/CT imagingAlso: Positron emission tomography - computed tomographyStandard of Care | Procedure or surgery | Radioactive Iodide and PET/CT |
| Na134IAlso: GE Healthcare25 to 150 mCi | Drug | Radioactive Iodide and PET/CT |
| Tri-iodothyronineAlso: T375 ug/8hr x 4 weeks; oral | Drug | Radioactive Iodide and PET/CT |
| Tri-iodothyronineAlso: T320 mg/day x 2 | Drug | Radioactive Iodide and PET/CT |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene L. Wapnir principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 124 PET/CT imaging, Na134I and Tri-iodothyronine in people with Breast Cancer and Metastatic Breast Cancer, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2016.