Breast Cancer PSMA PET

NCT06586047 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 202306462
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Triple Negative Breast Cancer

Keywords

Breast cancer, PSMA expression, PET imaging

Outcome Measures

Primary Outcomes (1)

• Lesion detection sensitivity analysis

  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 Outcomes (1)

• Quantitative radiotracer uptake analysis

  4 weeks

Study Arms (1)

PET Imaging of breast cancer patients

EXPERIMENTAL

Triple negative breast cancer patients will undergo FDG PET/CT and Pyl PET/Ct

Diagnostic Test: PET imaging

Interventions

PET imaging DIAGNOSTIC_TEST

Imaging with FDG PET/CT and Pyl PET/CT in triple negative breast cancer

PET Imaging of breast cancer patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ahmad Shariftabrizi: lead
• Progenics Pharmaceuticals, Inc.: collaborator

Study Sites (1)

University of Iowa Healthcare

Iowa City, Iowa, 52242, United States

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Breast Neoplasms

Interventions

Positron-Emission Tomography

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Central Study Contacts

Ahmad Shariftabrizi, M.D.

CONTACT

319-887-4942; ashariftabrizi@uiowa.edu

Elina Shrestha

CONTACT

319 335 0114; eshrestha@uiowa.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 19, 2024
• Study Start: August 29, 2024
• Primary Completion (Estimated): December 29, 2026
• Study Completion (Estimated): December 29, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (1)