Recruiting
Early Phase 1

PSMA

Sponsor:

Ahmad Shariftabrizi

Code:

NCT06586047

Conditions

Triple Negative Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

PET imaging

Study Details

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

Study ID

NCT06586047

Start date

Aug 29, 2024

Status verified date

Aug, 2026

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Dec 29, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: PET Imaging of breast cancer patients

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

Interventions

PET imaging

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

Primary outcome measure

  • Lesion detection sensitivity analysis [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Ahmad Shariftabrizi, M.D.

319-887-4942ashariftabrizi@uiowa.edu

Elina Shrestha

319 335 0114eshrestha@uiowa.edu

Locations

University of Iowa Healthcare

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Ahmad Shariftabrizi, M.D.

319-887-4942ashariftabrizi@uiowa.edu

More Information

Sponsor

Ahmad Shariftabrizi

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • Breast cancer, PSMA expression, PET imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ahmad Shariftabrizi on 2026-08-06.