Metastatic Breast Cancer to the BrainNCT01621906
18F-FLT-PET Imaging of the Brain in Patients With Metastatic Breast Cancer to the Brain Treated With Whole Brain Radiation Therapy With or Without Sorafenib: Comparison With MR Imaging of the Brain
A study testing 18F-FLT-PET Imaging in people with Metastatic Breast Cancer to the Brain, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.
Trial summary
The purpose of this study is to compare two different imaging methods to examine the response of brain metastases to WBRT. These two imaging methods will take pictures of the brain using : 1) a positron emission tomography (PET) scanner and 2) Magnetic Resonance Imaging (MRI) scanner. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer to the Brain
- What is being tested?
- 18F-FLT-PET Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 6 sitesUnited States
- Study dates
- 13 Jun 2012to 27 May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histologically-confirmed (confirmation done at MSKCC) metastatic adenocarcinoma of the breast
- Radiologic evidence of new and/or progressive brain metastases ((≥10 mm in longest dimension) by MRI imaging of the Brain
- Planned WBRT based on number (≥ 3 lesions) and/or size (≥ 1 cm) of brain metastases.
- Age ≥18 years; males and females
- Patients who require additional clinically indicated stereotactic radiosurgery (SRS) in addition to WBRT will also be eligible.
- Life expectancy of >12 weeks.
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- Karnofsky Performance Status (KPS) ≥ 70%.
- Creatinine ≤2.0 times the upper limit of normal.
- Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to enrollment, must be non-lactating and must agree to use adequate contraception prior to enrollment and for the duration of study participation.
- No limit to prior therapies with last anti-cancer treatment ≥2 weeks from initiation of WBRT. Please note: there is no washout period required for trastuzumab, pertuzumab, for patients who have developed new parenchymal brain metastases while on these agents.
Who cannot join
- Leptomeningeal metastases Please note: leptomeningeal metastases may be allowed if it is limited to cranial metastasis (MRI spine should be completed, within 4 weeks of enrollment, to show that no other leptomeningeal metastases is present) and is not the only metastasis present in the brain.
- Concurrent administration of lapatinib or other tyrosine kinase inhibitors other than sorafenib
- Craniotomy or any other major surgery, open biopsy, or significant traumatic injury within 4 weeks of randomization.
- Concurrent anti-cancer therapy (chemotherapy, hormonal therapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than sorafenib, and protocol-specified whole-brain radiotherapy.
- Use of any investigational drug within 30 days or 5 half-lives, whichever is longer, preceding enrollment.
- Inability to comply with protocol and /or not willing or not available for follow-up assessments.
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- Any condition which in the investigator's opinion makes the patient unsuitable for the study participation.
- Patient is incontinent of urine or stool (which would make them unable to tolerate lying still for 60 minutes).
- Claustrophobia
- Known allergic reaction to Gd-DTPA
- Renal insufficiency with recent (<3 month old) creatinine >2.0
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering at Mercy Medical Center
Rockville Centre, New York
About this study
Official title: Pilot Study of 18F-FLT-PET Imaging of the Brain in Patients With Metastatic Breast Cancer to the Brain Treated With Whole Brain Radiation Therapy With or Without Sorafenib: Comparison With MR Imaging of the Brain
The purpose of this study is to compare two different imaging methods to examine the response of brain metastases to WBRT. These two imaging methods will take pictures of the brain using : 1) a positron emission tomography (PET) scanner and 2) Magnetic Resonance Imaging (MRI) scanner. A PET scanner resembles a CT or MR scanner.PET scans use radioactive substances also called as radioactive markers to "see" cancer cells. We plan to use [18F]FLT as a radioactive marker. FLT is used to image tumor growth. FLT PET scan is a new clinical procedure. It is in the testing stage of development unlike FDG-PET which is used more commonly used. Therefore, this is considered a "research" study. This will help us evaluate whether this scan will be safe and better used in the future to evaluate tumors. The amount of radiation to the body is small. The radiation from the radiotracer drug will be gone from the body in a few hours. There is no radiation risk from the MRI scans. Additionally, we also plan to use MRI imaging of the brain. We expect that [18F]FLT PET is better when compared to MRI and will give us more information about the brain metastases after WBRT.
- Conditions
- Metastatic Breast Cancer to the Brain
- Being tested
- 18F-FLT-PET Imaging
- Keywords
- Breast, brain metastases, 18F-FLT-PET Imaging, FLT(3'DEOXY-3'FLUOROTHYMIDINE), MR Imaging, 12-039
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FLT-PET ImagingDevice
All patients will be imaged using FLT-PET scans at baseline (within 4 weeks of initiation of WBRT), 7-10 days after completion of WBRT and then 10-12 weeks after WBRT.
Patients will also be evaluated with MRI imaging at baseline and then 10-12 weeks after WBRT.
Patients will be followed with MRI every 3 months (+/- 7 days) for the first year and then every 6 months (+/- 7 days) thereafter which is the standard of care.
18F-FLT-PET ImagingDevice
All patients will be imaged using FLT-PET scans at baseline (within 4 weeks of initiation of WBRT), 7-10 days after completion of WBRT and then 10-12 weeks after WBRT.
Patients will also be evaluated with MRI imaging at baseline and then 10-12 weeks after WBRT.
Patients will be followed with MRI every 3 months (+/- 7 days) for the first year and then every 6 months (+/- 7 days) thereafter which is the standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Cohort 1 will include the first ten patients treated with WBRT concomitantly with sorafenib (on a separate phase I trial). We will perform a pilot study of serial FLT-PET imaging of the brain at baseline (< 4 weeks prior to initiation of WBRT), up to 7-10 days post-WBRT and 10-12 weeks after WBRT in patients with metastatic breast cancer to the brain (N=20) treated with WBRT with or without sorafenib. Receives: Device: 18F-FLT-PET Imaging |
| Cohort 2 | Experimental | Cohort 2 will include patients treated with standard WBRT alone. Patients in both these cohorts will also be assessed with standard non-invasive MRI in addition to [18F] FLT PET at baseline (< 4 weeks of WBRT) and 10-12 weeks after completion of WBRT. Receives: Device: 18F-FLT-PET Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Overall Response Rate is the proportion of participants who had a complete or partial response (Cohort 1)
Measured: 1 year
Secondary outcomes (1)
Change in Avg SUV Max From Baseline to 1 Year
Comparing FLT PET findings with tissue analysis will enable us to determine if imaging results are concordant with histological findings and thus allow for confirmation of this hypothesis. In this manner, we propose to generate a bridge between tissue analysis and FLT-PET brain imaging studies. For patients needing to undergo craniotomy for resection of a brain metastasis after WBRT, tissue findings (radionecrosis versus viable tumor) will be correlated with radiologic assessment in an exploratory manner.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study start13 Jun 2012
- Primary completion27 May 2021
- Study completion27 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast Cancer to the BrainStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Seidman, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621906
- Sponsor's protocol ID
- 12-039
- Status last verified
- Jun 2021
- First submitted
- 14 Jun 2012
- Last updated
- 9 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Morikawa A, Grkovski M, Patil S, Jhaveri KL, Tang K, Humm JL, Holodny A, Beal K, Schoder H, Seidman AD. A phase I trial of sorafenib with whole brain radiotherapy (WBRT) in breast cancer patients with brain metastases and a correlative study of FLT-PET brain imaging. Breast Cancer Res Treat. 2021 Jul;188(2):415-425. doi: 10.1007/s10549-021-06209-4. Epub 2021 Jun 10.
PubMed 34109515
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of 18F-FLT-PET Imaging of the Brain in Patients With Metastatic Breast Cancer to the Brain Treated With Whole Brain Radiation Therapy With or Without Sorafenib: Comparison With MR Imaging of the Brain
- ClinicalTrials.gov ID
- NCT01621906
- Acronym / sponsor ID
- 12-039
- Conditions
- Metastatic Breast Cancer to the Brain
- Keywords
- Breast, brain metastases, 18F-FLT-PET Imaging, FLT(3'DEOXY-3'FLUOROTHYMIDINE), MR Imaging, 12-039
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 13 Jun 2012 (actual)
- Primary completion
- 27 May 2021 (actual)
- Study completion
- 27 May 2021 (actual)
- First posted
- 18 Jun 2012 (estimated)
- Results
- Posted 9 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare two different imaging methods to examine the response of brain metastases to WBRT. These two imaging methods will take pictures of the brain using : 1) a positron emission tomography (PET) scanner and 2) Magnetic Resonance Imaging (MRI) scanner. A PET scanner resembles a CT or MR scanner.PET scans use radioactive substances also called as radioactive markers to "see" cancer cells. We plan to use [18F]FLT as a radioactive marker. FLT is used to image tumor growth. FLT PET scan is a new clinical procedure. It is in the testing stage of development unlike FDG-PET which is used more commonly used. Therefore, this is considered a "research" study. This will help us evaluate whether this scan will be safe and better used in the future to evaluate tumors. The amount of radiation to the body is small. The radiation from the radiotracer drug will be gone from the body in a few hours. There is no radiation risk from the MRI scans. Additionally, we also plan to use MRI imaging of the brain. We expect that [18F]FLT PET is better when compared to MRI and will give us more information about the brain metastases after WBRT.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Device: 18F-FLT-PET ImagingCohort 1 will include the first ten patients treated with WBRT concomitantly with sorafenib (on a separate phase I trial). We will perform a pilot study of serial FLT-PET imaging of the brain at baseline (< 4 weeks prior to initiation of WBRT), up to 7-10 days post-WBRT and 10-12 weeks after WBRT in patients with metastatic breast cancer to the brain (N=20) treated with WBRT with or without sorafenib. |
| Cohort 2 | Experimental | Device: 18F-FLT-PET ImagingCohort 2 will include patients treated with standard WBRT alone. Patients in both these cohorts will also be assessed with standard non-invasive MRI in addition to [18F] FLT PET at baseline (< 4 weeks of WBRT) and 10-12 weeks after completion of WBRT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically-confirmed (confirmation done at MSKCC) metastatic adenocarcinoma of the breast
- Radiologic evidence of new and/or progressive brain metastases ((≥10 mm in longest dimension) by MRI imaging of the Brain
- Planned WBRT based on number (≥ 3 lesions) and/or size (≥ 1 cm) of brain metastases.
- Age ≥18 years; males and females
- Patients who require additional clinically indicated stereotactic radiosurgery (SRS) in addition to WBRT will also be eligible.
Key exclusion criteria (11 listed)
- Leptomeningeal metastases Please note: leptomeningeal metastases may be allowed if it is limited to cranial metastasis (MRI spine should be completed, within 4 weeks of enrollment, to show that no other leptomeningeal metastases is present) and is not the only metastasis present in the brain.
- Concurrent administration of lapatinib or other tyrosine kinase inhibitors other than sorafenib
- Craniotomy or any other major surgery, open biopsy, or significant traumatic injury within 4 weeks of randomization.
- Concurrent anti-cancer therapy (chemotherapy, hormonal therapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than sorafenib, and protocol-specified whole-brain radiotherapy.
- Use of any investigational drug within 30 days or 5 half-lives, whichever is longer, preceding enrollment.
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 |
|---|---|---|
| 18F-FLT-PET ImagingAll patients will be imaged using FLT-PET scans at baseline (within 4 weeks of initiation of WBRT), 7-10 days after completion of WBRT and then 10-12 weeks after WBRT. Patients will also be evaluated with MRI imaging at baseline and then 10-12 weeks after WBRT. Patients will be followed with MRI every 3 months (+/- 7 days) for the first year and then every 6 months (+/- 7 days) thereafter which is the standard of care. | Device | Cohort 1 |
| 18F-FLT-PET ImagingAll patients will be imaged using FLT-PET scans at baseline (within 4 weeks of initiation of WBRT), 7-10 days after completion of WBRT and then 10-12 weeks after WBRT. Patients will also be evaluated with MRI imaging at baseline and then 10-12 weeks after WBRT. Patients will be followed with MRI every 3 months (+/- 7 days) for the first year and then every 6 months (+/- 7 days) thereafter which is the standard of care. | Device | Cohort 2 |
Primary outcome
Overall Response Rate
Time frame: 1 year
Overall Response Rate is the proportion of participants who had a complete or partial response (Cohort 1)
1 secondary outcome
Change in Avg SUV Max From Baseline to 1 Year
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34109515Morikawa A, Grkovski M, Patil S, Jhaveri KL, Tang K, Humm JL, Holodny A, Beal K, Schoder H, Seidman AD. A phase I trial of sorafenib with whole brain radiotherapy (WBRT) in breast cancer patients with brain metastases and a correlative study of FLT-PET brain imaging. Breast Cancer Res Treat. 2021 Jul;188(2):415-425. doi: 10.1007/s10549-021-06209-4. Epub 2021 Jun 10.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Andrew Seidman, MD principal investigator
Memorial Sloan Kettering Cancer Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-FLT-PET Imaging in people with Metastatic Breast Cancer to the Brain, run by Memorial Sloan Kettering Cancer Center at 6 sites 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 10 inclusion and 11 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: finished, as of the sponsor's last update on 9 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Yes. Results are posted in the registry (first posted 9 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Response Rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01621906, which also lists 1 linked publication.
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 9 Sep 2022.