Breast CancerPhase 1NCT07899892
A Study of 68Ga-FAPI Breast PET/MRI Scans in People With Breast Cancer
A Phase 1 study testing 68Ga-FAPI-PET/MRI in people with Breast Cancer and Invasive Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
Trial summary
The purpose of this study is to find out whether it is practical (feasible) to use a new type of imaging scan called 68Ga-FAPI PET/MRI (positron emission tomography/magnetic resonance imaging) to evaluate how well breast cancer responds to neoadjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Invasive Breast Cancer
- What is being tested?
- 68Ga-FAPI-PET/MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 8 sitesUnited States
- Study dates
- 20 Oct 2026to 20 Oct 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- ECOG Performance Status of ≤ 2
- Ability to review and signed informed consent
- Histologically confirmed, newly diagnosed invasive breast cancer
- Lymph node metastases (either histologically confirmed or radiographic evidence of lymph node metastases).
- Planned to undergo SOC NAC prior to surgical resection as outlined in section 4.1
Who cannot join
- Pregnancy or lactation.
- Patients who cannot undergo PET/MRI scanning because of:
- devices or implants that are not MRI safe
- hypersensitivity or known allergy to gadolinium-based contrast agents
- physical fitness not allowing scanning in prone for 30 minutes
- weight limits (450 lb. weight limit)
Show all 9Show fewer
- Severe kidney disfunction (estimated GFR < 30 ml/min/1.73 m2) (CKD-EPI (2021))
- Imaging features suspicious for concomitant in-situ cancer (LCIS/DCIS), such as nonbiopsied groups of microcalcifications
- Distant metastases (contraindication for NAC)
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Roberto Valentin, MD contact
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Somali Gavane, MD, 212-639-2403
- Recruiting
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Commack, New York, 11725
Simone Gavane, MD, 212-639-2403
- Recruiting
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activity)
Commack, New York, 11725
Somali Gavane, MD, 212-639-2403
- Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Simone Gavane, MD, 212-639-2403
- Recruiting
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, 07748
Somali Gavane, MD, 212-639-2403
- Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Somali Gavane, MD, 212-639-2403
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Somali Gavane, MD, 212-639-2403
- Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, 11553
Simone Gavane, MD, 212-639-2403
About this study
Official title: A Prospective Study to Evaluate the Feasibility of 68Ga-FAPI Breast PET/MRI in Diagnosing a Breast Cancer Pathologic Complete Response Following Neoadjuvant Chemotherapy
The purpose of this study is to find out whether it is practical (feasible) to use a new type of imaging scan called 68Ga-FAPI PET/MRI (positron emission tomography/magnetic resonance imaging) to evaluate how well breast cancer responds to neoadjuvant chemotherapy.
- Conditions
- Breast Cancer, Invasive Breast Cancer
- Being tested
- 68Ga-FAPI-PET/MRI
- Keywords
- Breast Cancer, Invasive Breast Cancer, 68Ga-FAPI, Memorial Sloan Kettering Cancer Center, 26-320
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FAPI-PET/MRIDiagnostic test
68Ga-FAPI-PET/MRI is conducted 3 times in every participant.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Breast Cancer | Experimental | Participants with histologically confirmed, newly diagnosed invasive breast cancer Receives: Diagnostic Test: 68Ga-FAPI-PET/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants able to complete all 3 planned scans
The primary aim of the study is to assess the feasibility to non-invasively assess response to NAC with 68Ga-FAPI-PET/MRI. Feasibility is given if a participant is able to complete all 3 planned scans.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start20 Oct 2026
- Primary completion20 Oct 2028 (estimated)
- Study completion20 Oct 2028 (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 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Somali Gavane, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899892
- Sponsor's protocol ID
- 26-320
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate the Feasibility of 68Ga-FAPI Breast PET/MRI in Diagnosing a Breast Cancer Pathologic Complete Response Following Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT07899892
- Acronym / sponsor ID
- 26-320
- Conditions
- Breast Cancer, Invasive Breast Cancer
- Keywords
- Breast Cancer, Invasive Breast Cancer, 68Ga-FAPI, Memorial Sloan Kettering Cancer Center, 26-320
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 20 Oct 2026 (actual)
- Primary completion
- 20 Oct 2028 (estimated)
- Study completion
- 20 Oct 2028 (estimated)
- First posted
- 28 Oct 2026 (actual)
- 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.
The purpose of this study is to find out whether it is practical (feasible) to use a new type of imaging scan called 68Ga-FAPI PET/MRI (positron emission tomography/magnetic resonance imaging) to evaluate how well breast cancer responds to neoadjuvant chemotherapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Breast Cancer | Experimental | Diagnostic Test: 68Ga-FAPI-PET/MRIParticipants with histologically confirmed, newly diagnosed invasive breast cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18
- ECOG Performance Status of ≤ 2
- Ability to review and signed informed consent
- Histologically confirmed, newly diagnosed invasive breast cancer
- Lymph node metastases (either histologically confirmed or radiographic evidence of lymph node metastases).
Key exclusion criteria (9 listed)
- Pregnancy or lactation.
- Patients who cannot undergo PET/MRI scanning because of:
- Severe kidney disfunction (estimated GFR < 30 ml/min/1.73 m2) (CKD-EPI (2021))
- Imaging features suspicious for concomitant in-situ cancer (LCIS/DCIS), such as nonbiopsied groups of microcalcifications
- Distant metastases (contraindication for NAC)
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 |
|---|---|---|
| 68Ga-FAPI-PET/MRI68Ga-FAPI-PET/MRI is conducted 3 times in every participant. | Diagnostic test | Participants with Breast Cancer |
Primary outcome
Number of participants able to complete all 3 planned scans
Time frame: Up to 1 year
The primary aim of the study is to assess the feasibility to non-invasively assess response to NAC with 68Ga-FAPI-PET/MRI. Feasibility is given if a participant is able to complete all 3 planned scans.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Roberto Valentin, MD contact
Somali Gavane, MD principal investigator
Memorial Sloan Kettering Cancer Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 68Ga-FAPI-PET/MRI in people with Breast Cancer and Invasive Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 8 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 6 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: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Somali Gavane, MD (212-639-2403, GavaneS@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants able to complete all 3 planned scans (time frame: Up to 1 year). 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 28 Oct 2026.