PSMA Imaging for Breast Cancer
Palo Alto (17 mi)Overseen bySteve Y Cho, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Wisconsin, Madison
No Placebo Group
Prior Safety Data
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?This trial uses a new imaging substance in scans to study specific markers in patients with a certain type of breast cancer. It aims to understand why some treatments don't work well for these patients.
Is the drug used in PSMA Imaging for Breast Cancer a promising treatment?The drug used in PSMA Imaging, known as 18F-DCFPyL, is promising because it helps doctors see cancer more clearly. It is especially useful in detecting prostate cancer, and it could potentially help in breast cancer by providing better images for diagnosis and treatment planning.13789
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial investigators for more details.
What safety data exists for PSMA imaging treatment?The safety data for PSMA imaging treatment, specifically using the radiotracer [18F]DCFPyL, has been primarily evaluated in the context of prostate cancer. Initial studies have focused on its safety, biodistribution, and radiation dosimetry in patients with prostate cancer. While the research primarily targets prostate cancer, there is also exploration of its use in other cancers like colon, gastric, and pancreatic cancer. However, these studies do not specifically address breast cancer, and the safety data for breast cancer patients may not be directly available from the existing literature.124510
What data supports the idea that PSMA Imaging for Breast Cancer (also known as: 18F-DCFPyL, PyL-PSMA-11, 18F-DCFPyL PET/CT) is an effective treatment?The available research does not provide data supporting the effectiveness of PSMA Imaging for Breast Cancer. The studies focus on the use of 18F-DCFPyL PET/CT for prostate cancer and other types of cancer, like colon, gastric, and pancreatic cancers. For prostate cancer, the research shows that 18F-DCFPyL PET/CT is better at finding cancerous lesions compared to traditional imaging methods. However, for other cancers, like colon, gastric, and pancreatic, the imaging was less effective compared to another method called 18F-FDG PET/CT. There is no specific data on its effectiveness for breast cancer in the provided information.246810
Eligibility Criteria
This trial is for people with a specific type of advanced breast cancer that doesn't respond to usual hormone therapies (HER2-negative, AR-positive). They must have at least 10% AR expression in their tumors. It's not for those with other active cancers, who can't lie flat for scans, or women who could be pregnant or are breastfeeding.Inclusion Criteria
My breast cancer is metastatic, HER2-negative with AR expression ≥ 10%.
Exclusion Criteria
I cannot lie flat for scans.
I am not pregnant or breastfeeding, confirmed by a recent test.
Treatment Details
The study is testing the presence of PSMA in certain breast cancers and its link to resistance against anti-androgen therapy like bicalutamide. Researchers think PSMA might help identify which patients would benefit from these treatments. Participants will undergo PET/CT scans using a tracer called 18F-DCFPyL.
1Treatment groups
Experimental Treatment
Group I: 18F-DCFPyL PSMA-based PET/CTExperimental Treatment1 Intervention
* 18F-DCFPyL whole body PET/CT scan
* Review of relevant imaging and medical record information
* Blood draw for circulating tumor cells (CTCs)
* Analysis of diagnostic tissue specimens
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of Wisconsin School of Medicine and Public HealthMadison, WI
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Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
References
2-(3-{1-Carboxy-5-[(6-[18F]fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid, [18F]DCFPyL, a PSMA-based PET imaging agent for prostate cancer. [2021]We have synthesized and evaluated in vivo 2-(3-{1-carboxy-5-[(6-[(18)F]fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid, [(18)F]DCFPyL, as a potential imaging agent for the prostate-specific membrane antigen (PSMA). PSMA is upregulated in prostate cancer epithelia and in the neovasculature of most solid tumors.
Initial Evaluation of [(18)F]DCFPyL for Prostate-Specific Membrane Antigen (PSMA)-Targeted PET Imaging of Prostate Cancer. [2022]Prostate-specific membrane antigen (PSMA) is a recognized target for imaging prostate cancer. Here we present initial safety, biodistribution, and radiation dosimetry results with [(18)F]DCFPyL, a second-generation fluorine-18-labeled small-molecule PSMA inhibitor, in patients with prostate cancer.
Comparison of [(18)F]DCFPyL and [ (68)Ga]Ga-PSMA-HBED-CC for PSMA-PET Imaging in Patients with Relapsed Prostate Cancer. [2021]Gallium-68 (Ga-68)-labeled tracers for imaging expression of the prostate-specific membrane antigen (PSMA) such as the [(68)Ga]Ga-PSMA-HBED-CC have already demonstrated high potential for the detection of recurrent prostate cancer. However, compared to Ga-68, a labeling with fluorine-18 (F-18) would offer advantages with respect to availability, production amount, and image resolution. [(18)F]DCFPyL is a promising F-18-labeled candidate for PSMA-positron emission tomography (PET) imaging that has been recently introduced. In the current study, we aimed to compare [(68)Ga]Ga-PSMA-HBED-CC and [(18)F]DCFPyL for clinical use in biochemically relapsed prostate cancer.
PSMA-Based [(18)F]DCFPyL PET/CT Is Superior to Conventional Imaging for Lesion Detection in Patients with Metastatic Prostate Cancer. [2022]Current standard of care conventional imaging modalities (CIM) such as X-ray computed tomography (CT) and bone scan can be limited for detection of metastatic prostate cancer and therefore improved imaging methods are an unmet clinical need. We evaluated the utility of a novel second-generation low molecular weight radiofluorinated prostate-specific membrane antigen (PSMA)-targeted positron emission tomography (PET) radiotracer, [(18)F]DCFPyL, in patients with metastatic prostate cancer.
Imaging of Prostate-Specific Membrane Antigen Using [18F]DCFPyL. [2022]Prostate-specific membrane antigen (PSMA) has been explored as a target for molecular imaging of prostate cancer and other malignancies that express PSMA in their tumor-associated neovasculature. Although several PSMA-targeted radiotracers labeled with a variety of radionuclides have been reported, positron-emitting radiotracers labeled with 18F are of particular interest. One such compound, the small molecule PSMA inhibitor [18F]DCFPyL, has demonstrated initial success. This article reviews the literature on this radiotracer, including radiosynthetic approaches to the molecule, data that are available from preclinical experiments, and evidence to date of the clinical utility of this agent in prostate cancer and clear cell renal cell carcinoma.
Low levels of PSMA expression limit the utility of 18F-DCFPyL PET/CT for imaging urothelial carcinoma. [2023]Label="OBJECTIVE" NlmCategory="OBJECTIVE">To explore the clinical utility of PSMA-targeted 18F-DCFPyL PET/CT in patients with metastatic urothelial carcinoma.
Combined model-based and patient-specific dosimetry for 18F-DCFPyL, a PSMA-targeted PET agent. [2018]Label="PURPOSE">Prostate-specific membrane antigen (PSMA), a type-II integral membrane protein highly expressed in prostate cancer, has been extensively used as a target for imaging and therapy. Among the available PET radiotracers, the low molecular weight agents that bind to PSMA are proving particularly effective. We present the dosimetry results for 18F-DCFPyL in nine patients with metastatic prostate cancer.
Diagnostic performance of 18F-DCFPyL positron emission tomography/computed tomography for biochemically recurrent prostate cancer and change-of-management analysis. [2021]Label="INTRODUCTION" NlmCategory="BACKGROUND">Conventional imaging (CI) performs poorly to identify sites of disease in biochemically recurrent prostate cancer. 68Ga-PSMA-11 positron emission tomography/computed tomography (PET/CT) is most studied but has a very short half-life. This study reports the diagnostic performance of the novel prostate-specific membrane antigen (PSMA) radiotracer 18F-DCFPyL using real-life data and tumor board simulation to estimate the impact of 18F-DCFPyL PET on patient management.
Role of 18F-DCFPyL PET/CT in patients with suspected prostate cancer. [2022]Label="OBJECTIVE" NlmCategory="OBJECTIVE">Fluorine-18-2-(3-{1-carboxy-5-[(6-18F-flfluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid (18F-DCFPyL), a novel positron emission tomography/computed tomography (PET/CT) radiotracer that binds to the prostate specific membrane antigen (PSMA), is increasingly used for biochemically recurrent prostate cancer diagnostics. However, the 18F-DCFPyL characteristics of suspected prostate cancer (SPCa) have been even more rarely described. Herein, in this retrospective study, we describe the clinical impact of 18F-DCFPyL PET/CT imaging in SPCa.
Prostate-Specific Membrane Antigen Targeted Pet/CT Imaging in Patients with Colon, Gastric and Pancreatic Cancer. [2022]Current imaging modalities frequently misjudge disease stage in colorectal, gastric and pancreatic cancer. As treatment decisions are dependent on disease stage, incorrect staging has serious consequences. Previous preclinical research and case reports indicate that prostate-specific membrane antigen (PSMA)-targeted PET/CT imaging might provide a solution to some of these challenges. This prospective clinical study aims to assess the feasibility of [18F]DCFPyL PET/CT imaging to target and visualize primary colon, gastric and pancreatic cancer. In this prospective clinical trial, patients with colon, gastric and pancreatic cancer were included and underwent both [18F]DCFPyL and [18F]FDG PET/CT scans prior to surgical resection or (for gastric cancer) neoadjuvant therapy. Semiquantitative analysis of immunohistochemical PSMA staining was performed on the surgical resection specimens, and the results were correlated to imaging parameters. The results of this study demonstrate detection of the primary tumor by [18F]DCFPyL PET/CT in 7 out of 10 patients with colon, gastric and pancreatic cancer, with a mean tumor-to-blood pool ratio (TBR) of 3.3 and mean SUVmax of 3.6. However, due to the high surrounding uptake, visual distinction of these tumors was difficult, and the SUVmax and TBR on [18F]FDG PET/CT were significantly higher than on [18F]DCFPyL PET/CT. In addition, no correlation between PSMA expression in the resection specimen and SUVmax on [18F]DCFPyL PET/CT was found. In conclusion, the detection of several gastrointestinal cancers using [18F]DCFPyL PET/CT is feasible. However, low tumor expression and high uptake physiologically in organs/background hamper the clear distinction of the tumor. As a result, [18F]FDG PET/CT was superior in detecting colon, gastric and pancreatic cancers.