Breast CancerNCT04149353
PET/MR in Surgical Planning for Breast CA Treated With Neoadj Chemo
A study testing PET/MR in people with Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
Purpose: To assess the utility of combined, simultaneous positron emission tomography (PET) and magnetic resonance imaging (MRI), collectively called PET-MR, in assessing response to neoadjuvant chemotherapy and surgical treatment decisions for operable breast cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- PET/MR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2018to 17 Feb 2020
- 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
- Age ≥ 18 years of age (no upper age limit)
- Signed, IRB-approved written informed consent
- Must have clinical T1-3, N0-3, M0 disease. All phenotypes are acceptable..
- Must have surgically curable disease as evaluated by the UNC Multidisciplinary Tumor Board.
- Must have pre- and post-treatment MRI imaging as part of the treatment plan.
- Must be able to meet size restrictions for the PET-MR scanner: chest depth and abdominal depth less than 27 cm (approximately the smallest 55% of women will meet this), as measured on imaging or with physical template.
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- Must be in acceptable health to undergo chemotherapy and curative intent surgery as assessed by Multidisciplinary Tumor Board.
- Must be able to understand and comply with study procedures for the entire length of the study.
- Must receive their chemotherapy and curative intent surgery at UNC Hospitals. -If patient has a history of prior malignancy, including melanoma, patient must be cancer- free for three or more years. Non-melanoma skin cancers will be included even if not cancer-free for three years.
- Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to each PET/MRI
Who cannot join
- Inability to tolerate MRI (e.g., inability to lie flat for >1 hour)
- Presence of pacemaker, intracranial aneurysm clip, bladder stimulator, cochlear implant or metal near eyes or near pelvis that would create excessive imaging artifact
- Poorly controlled diabetes mellitus
- Patient receiving neoadjuvant endocrine therapy (due to low likelihood of complete response)
- Pregnancy or lactating female
- Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study
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- Evidence of distant disease on physical exam or initial imaging
- Medical conditions precluding chemotherapy or curative intent surgery
- Incarcerated or otherwise institutionalized at time of enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Utility of PET/MR in Surgical Planning for Breast Cancer Treated With Neoadjuvant Chemotherapy
Purpose: To assess the utility of combined, simultaneous positron emission tomography (PET) and magnetic resonance imaging (MRI), collectively called PET-MR, in assessing response to neoadjuvant chemotherapy and surgical treatment decisions for operable breast cancers.
Participants: Adult patients with operable breast cancer that are being treated at UNC with neoadjuvant chemotherapy followed by potentially curative surgical resection.
Procedures (methods): Patients who are being treated with neoadjuvant chemotherapy followed by surgical resection and for whom pre- and post-treatment MR imaging is part of planned treatment will undergo additional pre-treatment and post-treatment PET/MR. The response to treatment will be assessed at post-treatment by evaluating change in tumor size from MRI, change in response to dynamic contrast enhanced (DCE) MRI, and 18F-fluorodeoxyglucose (18F-FDG) avidity from PET. Patients will then undergo surgery. Their pathology will be reviewed for treatment effect as assessed by residual cancer burden (RCB) score. Patients will be followed and assessed for recurrence.
Read the detailed description
Investigators propose that the changes indicated by PET/MR imaging from pre-treatment to post-treatment time points will accurately predict the patient's response to neoadjuvant chemotherapy, providing useful prognostic and surgical-planning information. The study will enroll patients with operable breast cancer being treated with neoadjuvant chemotherapy followed by potentially curative surgical resection. The standard of care for these patients would not normally include PET imaging but may include MR imaging. Patients in the study will receive combined PET/MR imaging prior to treatment and following treatment. Then, patients will receive curative intent surgery and be followed in the usual fashion and assessed for local and/or distant recurrent disease. The pathology report will be reviewed for therapy treatment effect as assessed by Residual Cancer Burden (RCB) score. Quantitative measures from PET and MRI will be computed: the change in PET tumor-mean standardized uptake value (SUV) and tumor size as assessed by MRI, from pre- to post-treatment. The image-based quantitative measures will be correlated with the pathology outcomes to evaluate predictability of the image measures for RCB score. Patients will be followed with the intent of further correlating image measures with clinical outcomes.
- Conditions
- Breast Cancer
- Being tested
- PET/MR
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MRDiagnostic test
Patient will be scheduled for a pre-treatment PET/MR and proceed to neoadjuvant chemotherapy per the direction of the medical oncologist. Within four weeks after completion of chemotherapy the patient will undergo a post-treatment PET/MR, and proceed for curative intent surgery if they are still surgical candidates.
| Study group | Role | What they receive |
|---|---|---|
| PET/MR | Experimental | Each patient will undergo two combined PET/MR scans. The pre-treatment and post-treatment combined PET/MR scans are for research purposes and not part of the patient's standard of care. Receives: Diagnostic Test: PET/MR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PET Activity Estimates From Pre-treatment to Post-treatment
Primary endpoint is the determination of the potential for PET activity estimates to predict RCB score in comparison with that of dynamic contrast enhanced (DCE) MRI. Treatment response will be determined on final pathological evaluation of the resected specimens by way of the RCB score.
Measured: Time Frame: Changes in image measures will be assessed from baseline scans, prior to therapy, to post-treatment scans, taken six months after baseline. Pathology data will be obtained post-surgery.
Secondary outcomes (1)
Performance of Metrics Combining Multiple Features From PET and MR in Prediction of Response to Therapy
Quantitative image measures from PET and MR will be compiled and an optimal linear regression will be derived between the image metrics and the outcome measure from pathology, the RCB score. Prediction performance of the regression relation will be assessed using a leave-one-out cross-validation approach.
Measured: Changes in image measures will be assessed from baseline scans, prior to therapy, to post-treatment scans, taken six months after baseline. Pathology data will be obtained post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start5 Dec 2018
- Primary completion20 Feb 2019
- Study completion17 Feb 2020
Why it stopped: Low recruitment
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.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Lalush, PhD, Principal investigator, UNC Biomedical Engineering
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149353
- Sponsor's protocol ID
- LCCC 1716
- Status last verified
- Jun 2020
- First submitted
- 14 Mar 2019
- Last updated
- 16 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of PET/MR in Surgical Planning for Breast Cancer Treated With Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT04149353
- Acronym / sponsor ID
- LCCC 1716
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 17 Feb 2020 (actual)
- First posted
- 4 Nov 2019 (actual)
- Results
- Posted 6 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: To assess the utility of combined, simultaneous positron emission tomography (PET) and magnetic resonance imaging (MRI), collectively called PET-MR, in assessing response to neoadjuvant chemotherapy and surgical treatment decisions for operable breast cancers.
Participants: Adult patients with operable breast cancer that are being treated at UNC with neoadjuvant chemotherapy followed by potentially curative surgical resection.
Procedures (methods): Patients who are being treated with neoadjuvant chemotherapy followed by surgical resection and for whom pre- and post-treatment MR imaging is part of planned treatment will undergo additional pre-treatment and post-treatment PET/MR. The response to treatment will be assessed at post-treatment by evaluating change in tumor size from MRI, change in response to dynamic contrast enhanced (DCE) MRI, and 18F-fluorodeoxyglucose (18F-FDG) avidity from PET. Patients will then undergo surgery. Their pathology will be reviewed for treatment effect as assessed by residual cancer burden (RCB) score. Patients will be followed and assessed for recurrence.
Detailed description
Investigators propose that the changes indicated by PET/MR imaging from pre-treatment to post-treatment time points will accurately predict the patient's response to neoadjuvant chemotherapy, providing useful prognostic and surgical-planning information. The study will enroll patients with operable breast cancer being treated with neoadjuvant chemotherapy followed by potentially curative surgical resection. The standard of care for these patients would not normally include PET imaging but may include MR imaging. Patients in the study will receive combined PET/MR imaging prior to treatment and following treatment. Then, patients will receive curative intent surgery and be followed in the usual fashion and assessed for local and/or distant recurrent disease. The pathology report will be reviewed for therapy treatment effect as assessed by Residual Cancer Burden (RCB) score. Quantitative measures from PET and MRI will be computed: the change in PET tumor-mean standardized uptake value (SUV) and tumor size as assessed by MRI, from pre- to post-treatment. The image-based quantitative measures will be correlated with the pathology outcomes to evaluate predictability of the image measures for RCB score. Patients will be followed with the intent of further correlating image measures with clinical outcomes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET/MR | Experimental | Diagnostic Test: PET/MREach patient will undergo two combined PET/MR scans. The pre-treatment and post-treatment combined PET/MR scans are for research purposes and not part of the patient's standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years of age (no upper age limit)
- Signed, IRB-approved written informed consent
- Must have clinical T1-3, N0-3, M0 disease. All phenotypes are acceptable..
- Must have surgically curable disease as evaluated by the UNC Multidisciplinary Tumor Board.
- Must have pre- and post-treatment MRI imaging as part of the treatment plan.
Key exclusion criteria (9 listed)
- Inability to tolerate MRI (e.g., inability to lie flat for >1 hour)
- Presence of pacemaker, intracranial aneurysm clip, bladder stimulator, cochlear implant or metal near eyes or near pelvis that would create excessive imaging artifact
- Poorly controlled diabetes mellitus
- Patient receiving neoadjuvant endocrine therapy (due to low likelihood of complete response)
- Pregnancy or lactating female
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 |
|---|---|---|
| PET/MRPatient will be scheduled for a pre-treatment PET/MR and proceed to neoadjuvant chemotherapy per the direction of the medical oncologist. Within four weeks after completion of chemotherapy the patient will undergo a post-treatment PET/MR, and proceed for curative intent surgery if they are still surgical candidates. | Diagnostic test | PET/MR |
Primary outcome
Change in PET Activity Estimates From Pre-treatment to Post-treatment
Time frame: Time Frame: Changes in image measures will be assessed from baseline scans, prior to therapy, to post-treatment scans, taken six months after baseline. Pathology data will be obtained post-surgery.
Primary endpoint is the determination of the potential for PET activity estimates to predict RCB score in comparison with that of dynamic contrast enhanced (DCE) MRI. Treatment response will be determined on final pathological evaluation of the resected specimens by way of the RCB score.
1 secondary outcome
Performance of Metrics Combining Multiple Features From PET and MR in Prediction of Response to Therapy
Time frame: Changes in image measures will be assessed from baseline scans, prior to therapy, to post-treatment scans, taken six months after baseline. Pathology data will be obtained post-surgery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- UNC Lineberger Comprehensive Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
David Lalush, PhD principal investigator
UNC Biomedical Engineering
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET/MR in people with Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center 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 10 inclusion and 9 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: stopped early, as of the sponsor's last update on 16 Jun 2020. 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?
Yes. Results are posted in the registry (first posted 6 Mar 2020). 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?
Change in PET Activity Estimates From Pre-treatment to Post-treatment (time frame: Time Frame: Changes in image measures will be assessed from baseline scans, prior to therapy, to post-treatment scans, taken six months after baseline. Pathology data will be obtained post-surgery.). 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 16 Jun 2020.