Triple Negative Breast CancerEarly Phase 1NCT06586047
Breast Cancer PSMA PET
A Early Phase 1 study testing PET imaging in people with Triple Negative Breast Cancer, run by Ahmad Shariftabrizi at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- PET imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2024to 1 Sep 2027
- Phase
- Early 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 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Iowa Healthcare
Iowa City, Iowa, 52242
Ahmad Shariftabrizi, M.D., 319-887-4942, ashariftabrizi@uiowa.edu
About this study
Official title: 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.
Read the 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).
- Conditions
- Triple Negative Breast Cancer
- Being tested
- PET imaging
- Keywords
- Breast cancer, PSMA expression, PET imaging
- Medical subject headings
- Triple Negative Breast Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET imagingDiagnostic test
Imaging with FDG PET/CT and Pyl PET/CT in triple negative breast cancer
| Study group | Role | What they receive |
|---|---|---|
| PET Imaging of breast cancer patients | Experimental | Triple negative breast cancer patients will undergo FDG PET/CT and Pyl PET/Ct Receives: Diagnostic Test: PET imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (1)
Quantitative radiotracer uptake analysis
To quantitively compare the SUVs in each lesion on 18 F-DCFPyL-PET/CT and FDG PET/CT.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start29 Aug 2024
- Primary completion29 Dec 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmad Shariftabrizi
- Sponsor type
- University, hospital or other
- Collaborators
- Progenics Pharmaceuticals, Inc.
- Responsible party
- Sponsor-investigator, Ahmad Shariftabrizi, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586047
- Sponsor's protocol ID
- 202306462
- Status last verified
- Aug 2026
- First submitted
- 3 Sep 2024
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of PSMA Expression in Triple Negative Breast Cancer Patients Using 18 F-DCFPyL-PET/CT
- ClinicalTrials.gov ID
- NCT06586047
- Acronym / sponsor ID
- 202306462
- Conditions
- Triple Negative Breast Cancer
- Keywords
- Breast cancer, PSMA expression, PET imaging
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ahmad ShariftabriziUniversity, hospital or other
- Collaborators
- Progenics Pharmaceuticals, Inc.
- Study start
- 29 Aug 2024 (actual)
- Primary completion
- 29 Dec 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 19 Sep 2024 (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 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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET Imaging of breast cancer patients | Experimental | Diagnostic Test: PET imagingTriple negative breast cancer patients will undergo FDG PET/CT and Pyl PET/Ct |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| PET imagingImaging with FDG PET/CT and Pyl PET/CT in triple negative breast cancer | Diagnostic test | PET Imaging of breast cancer patients |
Primary outcome
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.
1 secondary outcome
Quantitative radiotracer uptake analysis
Time frame: 4 weeks
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 6 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing PET imaging in people with Triple Negative Breast Cancer, run by Ahmad Shariftabrizi 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 3 inclusion and 4 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 6 Aug 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Ahmad Shariftabrizi, M.D. (319-887-4942, ashariftabrizi@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion detection sensitivity analysis (time frame: 4 weeks). 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 6 Aug 2026.