Breast Cancer PSMA PET

March 23, 2026 updated by: Ahmad Shariftabrizi

Evaluation of PSMA Expression in Triple Negative Breast Cancer Patients Using 18 F-DCFPyL-PET/CT

The purpose of this research is to determine the expression of Prostate Specific Membrane Antigen(PSMA) in metastatic Triple Negative Breast Cancer (TNBC) patients using Fludeoxyglucose F18 (FDG) PET/CT as the gold standard. The investigators hypothesize that most lesions in metastatic TNBC are PSMA-avid; and thus PSMA-based radionuclide therapy can be a valid treatment option for TNBC, and clinical trials can be designed for this purpose. Thirty metastatic TNBC patients will be enrolled and will be on the study for maximum of 4 weeks.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Prostate Specific Membrane Antigen (PSMA) is not only expressed in prostate cancer and its metastases, but also it is expressed on the neovasculature of many other solid tumors including gastric, lung, adrenal, bladder and renal cell carcinomas. Also, there is evidence that breast carcinomas express PSMA, although this has not been specifically studied in the metastatic TNBC.

The study involves a total of 2 visits and on each visit, patients will undergo a PET imaging. Each patient will first undergo an (FDG) PET/CT and then in few days will undergo an 18F-DCFPyL-PET/CT. The PET scanner is a large machine with a hollow tube that will be used to see how F18 FDG is taken up into the tumor and other tissues. The patients will be asked to lie on the back on a special table that slides into the tube. The sides of the tube will be close to the body. At the first visit patients will be in this scanner for approximately 20 minutes.

The study will evaluate the expression of PSMA via 18 F-DCFPyL-PET/CT in metastatic TNBC patients and compare it with lesion detection rate of FDG PET/CT. PSMA-avid lesions will be detected using the novel agent 18 F-DCFPyL and concordance rate with FDG-avid lesions will be calculated. The standardized uptake values (SUV) of each lesion on both FDG PET/CT and 18F-DCFPyL-PET/CT will be compared to find a correlation between tumor aggressiveness (lesion SUV on FDG PET/CT) and tumor angiogenesis (lesion SUV on 18 F-DCFPyL-PET/CT).

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Healthcare
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female >= 18 years of age
  • Patients in distantly metastatic TNBC based on the initial diagnosis biopsy.
  • Patient should have FDG positive metastatic lesions on the initial PET/CT scan performed in this study to be further included.

Exclusion Criteria:

  • Patients with known active other malignancy.
  • Unable to tolerate PET/CT procedure.
  • Pregnant or breastfeeding.
  • Patients with any medical condition that might compromise the safety of subject during PET acquisitions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PET Imaging of breast cancer patients
Triple negative breast cancer patients will undergo FDG PET/CT and Pyl PET/Ct
Diagnostic test: PET imaging
Imaging with FDG PET/CT and Pyl PET/CT in triple negative breast cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lesion detection sensitivity analysis
Time Frame: 4 weeks
Comparing the sensitivity of 18 F-DCFPyL-PET/CT and FDG PET/CT in metastatic lesion detection in triple-negative breast cancer patients.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative radiotracer uptake analysis
Time Frame: 4 weeks
To quantitively compare the SUVs in each lesion on 18 F-DCFPyL-PET/CT and FDG PET/CT.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ahmad Shariftabrizi

Collaborators

Progenics Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2024

Primary Completion (Estimated)

December 29, 2026

Study Completion (Estimated)

December 29, 2026

Study Registration Dates

First Submitted

September 3, 2024

First Submitted That Met QC Criteria

September 3, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202306462

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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