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Breast CancerPhase 2NCT07285993

Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET

A Phase 2 study testing 18F-FAPI-74, 18F-FDG and PET/CT in people with Breast Cancer and Metastatic Invasive Lobular Breast Cancer, run by Randy Yeh at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study is a pilot clinical imaging trial of a prospective, head-to-head comparison of 18F-Fibroblast Activation Protein Inhibitor (FAPI)-74 PET/CT versus standard-of-care 18F-Fluorodeoxyglucose (FDG) PET/CT in 15 patients with metastatic invasive lobular breast cancer (ILC). Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
18F-FAPI-74, 18F-FDG and PET/CT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
1 Jun 2026to 30 Dec 2027
Phase
Phase 2
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
  • Females; Age > 18 years of age
  • Diagnosis of invasive lobular breast cancer, with pathologically confirmed metastatic disease.
  • ECOG performance status 0-2
  • No planned change in anticancer therapy between FDG and FAPI PET scans

Who cannot join

  • Patients who are pregnant or lactating
  • Patients who cannot undergo PET/CT scanning
  • Patients with total serum bilirubin or serum creatinine > 1.5 times the upper limit of normal

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ilda Bander contact

(212) 241-0763

Ilda.Bander@mountsinai.org

Rashmi Unawane contact

(212) 824-2385

rashmi.unawane@mssm.edu

United States1 site

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    Ilda Bander, (212) 241-0763, Ilda.Bander@mountsinai.org

    Rashmi Unawane, 212-824-2385, Rashmi.Unawane@mssm.edu

Other trials in United States

About this study

Official title: Improving Detection and Outcomes in Patients With Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAPI PET Imaging

This study is a pilot clinical imaging trial of a prospective, head-to-head comparison of 18F-Fibroblast Activation Protein Inhibitor (FAPI)-74 PET/CT versus standard-of-care 18F-Fluorodeoxyglucose (FDG) PET/CT in 15 patients with metastatic invasive lobular breast cancer (ILC). Patients will undergo both 18F-FDG PET/CT and 18F-FAPI-74 PET/CT within a 2-week period (14 days + 7 days) to compare lesions, tumor detection rates, and PET lesion intensity, as well as to assess the clinical value of the PET scans from the treating physician's and the patient's perspective.

Being tested
18F-FAPI-74, 18F-FDG, PET/CT
Keywords
Breast Cancer, Novel F-18 FAPI PET, Metastatic, Invasive, Lobular, 18F-FDG PET/CT
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 18F-FAPI-74Drug

    FAPI scans will be performed as hybrid PET/CT examinations for attenuation correction and lesion localization. Each patient will be injected intravenously with 7 mCi +/- 2 mCi of 18F-FAPI-74 followed by a 20-minute (+/-10 min) uptake period.

  • 18F-FDGDrug

    FDG PET/CT will be performed per standard-of-care protocol at Mount Sinai Hospital. Patients will fast for at least 6 hours before FDG administration and plasma glucose levels will be checked to ensure < 200 mg/dL. Each patient will be injected intravenously with 15 mCi +/- 20% of 18F-FDG.

  • PET/CTProcedure or surgery

    FAPI PET/CT images will be acquired from the top of skull to mid-thigh. FDG PET/CT images will be acquired from the skull base to mid-thigh after a 60-min uptake period. Outside FDG PET/CT performed at another institutional can be accepted, if image quality and acquisition is comparable to standard-of-care protocol at Mount Sinai Hospital.

Study groups in NCT07285993
Study groupRoleWhat they receive
18F-FAPI-74 PET/CT and 18F-FDG PET/CTExperimentalStudy participants will undergo both standard-of-care whole body 18F-FDG PET/CT scan and investigational whole-body scan 18F-FAPI-74 PET/CT.
Receives: Drug: 18F-FAPI-74; Drug: 18F-FDG; Procedure: PET/CT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of lesions detected by 18F-FAPI-74 PET/CT

    Proportion of lesions detected by 18F-FAPI-74 PET/CT but not by 18F-FDG PET/CT. All lesions will be mapped across both imaging modalities to determine whether they were detected by FAPI PET/CT but not by FDG PET/CT.

    Measured: End of study, at 1 month

Secondary outcomes (7)

  1. Proportion of lesions detected by 18F-FDG PET/CT but not by 18F-FAPI-74 PET/CT

    All lesions will be mapped across both imaging modalities to determine whether they were detected by FDG PET/CT but not by FAPI PET/CT.

    Measured: End of study, at 1 month

  2. Proportion of concordant lesions detected by both 18F-FAPI-74 PET/CT and 18F-FDG PET/CT

    All lesions will be mapped across both imaging modalities to determine whether they were detected by both FAPI PET/CT and FDG PET/CT (i.e., concordant detection).

    Measured: End of study, at 1 month

  3. Tumor detection rate

    Tumor detection rate, defined as the proportion (%) of patients with >1 lesion on 18F-FAPI-74 PET/CT compared to 18F-FDG PET/CT

    Measured: End of study, at 1 month

  4. SUVmax of the hottest lesion (lesion with highest SUVmax) on 18F-FAPI-74 PET/CT compared to 18F-FDG PET/CT and mean SUVmax across all lesions

    SUVmax of each lesion identified on both 18F-FAPI-74 PET/CT and 18F-FDG PET/CT.

    Two summary metrics will be derived per patient per modality:

    Hottest lesion SUVmax: Defined as the highest SUVmax value among all detected lesions per patient per modality.

    Overall SUVmax: model lesion-level SUVmax values

    Measured: End of study, at 1 month

  5. Tumor-to-background ratio (TBR)

    Tumor-to-Background Ratio (TBR) will be defined as the SUVmax of the hottest lesion divided by the SUVmax of two background regions: the liver and the aortic blood pool.

    Measured: End of study, at 1 month

  6. Number of participants with change in therapeutic management decisions

    Number of participants with change in therapeutic management decisions following review of 18F-FAPI-74 PET/CT compared to decisions based on 18F-FDG PET/CT alone

    For each patient, an initial therapeutic management plan will be recorded based on findings from the 18F-FDG PET/CT scan alone. After the subsequent review of the 18F-FAPI-74 PET/CT scan, a revised management plan will be documented, reflecting any changes informed by the additional imaging data.

    Measured: End of study, at 1 month

  7. Change in disease status assessment

    Change in disease status assessment (responding, stable, progressing) by treating physicians following review of 18F-FAPI-74 PET/CT compared to assessment based on 18F-FDG PET/CT alone Treating physicians will assign a disease status classification (responding, stable, or progressing) based on available clinical and imaging data from 18F-FDG PET/CT and then after reviewing the 18F-FAPI-74 PET/CT scan. We will summarize the distribution of disease status before and after the FAPI scan, along with the number and percentages of patients whose disease status assessment changed following the FAPI scan, along with the specific nature of those changes.

    Measured: End of study, at 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2025
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion30 Dec 2027 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

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 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07285993
Sponsor's protocol ID
STUDY-25-00364
Other IDs
PRMC-25-041
Status last verified
Apr 2026
First submitted
11 Dec 2025
Last updated
1 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: The completed dataset is the sole property of the Sponsor-Investigator's institution and should not be exported to third parties, except for authorized representatives of appropriate Health/Regulatory Authorities, without permission from the Sponsor-investigator and their institution.

Publications

  • Choi ES, Oh AY, In CB, Ryu JH, Jeon YT, Kim HG. Effects of recruitment manoeuvre on perioperative pulmonary complications in patients undergoing robotic assisted radical prostatectomy: A randomised single-blinded trial. PLoS One. 2017 Sep 6;12(9):e0183311. doi: 10.1371/journal.pone.0183311. eCollection 2017.

    PubMed 28877238

  • Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.

    PubMed 31912902

  • Fischer S, Dethlefsen S, Klockgether J, Tummler B. Phenotypic and Genomic Comparison of the Two Most Common ExoU-Positive Pseudomonas aeruginosa Clones, PA14 and ST235. mSystems. 2020 Dec 8;5(6):e01007-20. doi: 10.1128/mSystems.01007-20.

    PubMed 33293405

  • Davis AA, Gerratana L, Clifton K, Medford AJ, Velimirovic M, Hensing WL, Bucheit L, Shah AN, D'Amico P, Reduzzi C, Zhang Q, Dai CS, Denault EN, Bagegni NA, Opyrchal M, Ademuyiwa FO, Bose R, Gradishar WJ, Behdad A, Ma CX, Bardia A, Cristofanilli M. Circulating tumour DNA characterisation of invasive lobular carcinoma in patients with metastatic breast cancer. EBioMedicine. 2022 Dec;86:104316. doi: 10.1016/j.ebiom.2022.104316. Epub 2022 Nov 1.

    PubMed 36332363

  • Dumans-Nizard V, Le Guen M, Sage E, Chazot T, Fischler M, Liu N. Thoracic Epidural Analgesia With Levobupivacaine Reduces Remifentanil and Propofol Consumption Evaluated by Closed-Loop Titration Guided by the Bispectral Index: A Double-Blind Placebo-Controlled Study. Anesth Analg. 2017 Aug;125(2):635-642. doi: 10.1213/ANE.0000000000001996.

    PubMed 28537969

  • Benham-Hutchins MM, Effken JA. Multi-professional patterns and methods of communication during patient handoffs. Int J Med Inform. 2010 Apr;79(4):252-67. doi: 10.1016/j.ijmedinf.2009.12.005. Epub 2010 Jan 15.

    PubMed 20079686

  • Niikura N, Costelloe CM, Madewell JE, Hayashi N, Yu TK, Liu J, Palla SL, Tokuda Y, Theriault RL, Hortobagyi GN, Ueno NT. FDG-PET/CT compared with conventional imaging in the detection of distant metastases of primary breast cancer. Oncologist. 2011;16(8):1111-9. doi: 10.1634/theoncologist.2011-0089. Epub 2011 Jul 17.

    PubMed 21765193

  • Dashevsky BZ, Goldman DA, Parsons M, Gonen M, Corben AD, Jochelson MS, Hudis CA, Morrow M, Ulaner GA. Appearance of untreated bone metastases from breast cancer on FDG PET/CT: importance of histologic subtype. Eur J Nucl Med Mol Imaging. 2015 Oct;42(11):1666-1673. doi: 10.1007/s00259-015-3080-z. Epub 2015 May 14.

    PubMed 25971426

  • Hogan MP, Goldman DA, Dashevsky B, Riedl CC, Gonen M, Osborne JR, Jochelson M, Hudis C, Morrow M, Ulaner GA. Comparison of 18F-FDG PET/CT for Systemic Staging of Newly Diagnosed Invasive Lobular Carcinoma Versus Invasive Ductal Carcinoma. J Nucl Med. 2015 Nov;56(11):1674-80. doi: 10.2967/jnumed.115.161455. Epub 2015 Aug 20.

    PubMed 26294295

  • Broudic M, Bodet LM, Dumont R, Joram N, Jacqmarcq O, Caillon J, Flamant C, Thomas C, Tallet A, Piloquet H, Lepelletier D, Gras-Le Guen C, Launay E. A 1-year survey of catheter-related infections in a pediatric university hospital: A prospective study. Arch Pediatr. 2020 Feb;27(2):79-86. doi: 10.1016/j.arcped.2019.11.004. Epub 2019 Nov 29.

    PubMed 31791827

  • Ciriello G, Gatza ML, Beck AH, Wilkerson MD, Rhie SK, Pastore A, Zhang H, McLellan M, Yau C, Kandoth C, Bowlby R, Shen H, Hayat S, Fieldhouse R, Lester SC, Tse GM, Factor RE, Collins LC, Allison KH, Chen YY, Jensen K, Johnson NB, Oesterreich S, Mills GB, Cherniack AD, Robertson G, Benz C, Sander C, Laird PW, Hoadley KA, King TA; TCGA Research Network; Perou CM. Comprehensive Molecular Portraits of Invasive Lobular Breast Cancer. Cell. 2015 Oct 8;163(2):506-19. doi: 10.1016/j.cell.2015.09.033.

    PubMed 26451490

  • Singh M, Jonnalagadda S. Design and characterization of 3D printed, neomycin-eluting poly-L-lactide mats for wound-healing applications. J Mater Sci Mater Med. 2021 Apr 8;32(4):44. doi: 10.1007/s10856-021-06509-7.

    PubMed 33830338

  • Garin-Chesa P, Old LJ, Rettig WJ. Cell surface glycoprotein of reactive stromal fibroblasts as a potential antibody target in human epithelial cancers. Proc Natl Acad Sci U S A. 1990 Sep;87(18):7235-9. doi: 10.1073/pnas.87.18.7235.

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  • Dwyer TJ, Daviskas E, Zainuldin R, Verschuer J, Eberl S, Bye PTP, Alison JA. Effects of exercise and airway clearance (positive expiratory pressure) on mucus clearance in cystic fibrosis: a randomised crossover trial. Eur Respir J. 2019 Apr 18;53(4):1801793. doi: 10.1183/13993003.01793-2018. Print 2019 Apr.

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  • Marchete R, Oliveira S, Bagne L, Silva JIS, Valverde AP, Aro AA, Figueira MM, Fronza M, Bressam TM, Goes VFF, Gaspari de Gaspi FO, Dos Santos GMT, Andrade TAM. Anti-inflammatory and antioxidant properties of Alternanthera brasiliana improve cutaneous wound healing in rats. Inflammopharmacology. 2021 Oct;29(5):1443-1458. doi: 10.1007/s10787-021-00862-3. Epub 2021 Sep 21.

    PubMed 34546478

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 18F-FAPI-74, 18F-FDG and PET/CT in people with Breast Cancer and Metastatic Invasive Lobular Breast Cancer, run by Randy Yeh 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 6 inclusion and 3 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: opening soon, as of the sponsor's last update on 1 May 2026. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Ilda Bander ((212) 241-0763, Ilda.Bander@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of lesions detected by 18F-FAPI-74 PET/CT (time frame: End of study, at 1 month). 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 NCT07285993, which also lists 25 linked publications.

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 1 May 2026.

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