A Phase 2 interventional study of PSMA-based 18F-DCFPyL PET tracer in Gynecologic Cancer, sponsored by University of Wisconsin, Madison. Terminated at 1 site in United States. Open to female participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-05.
Sponsored by University of Wisconsin, Madison · Phase 2, Interventional, and Diagnostic
The goal of this research is to determine the accuracy of PSMA positron emission tomography (PET) and multi-parametric magnetic resonance (MR) imaging to detect the presence of gynecological cancer cells in the body.
The investigators will evaluate a novel second-generation low-molecular-weight prostate specific membrane antigen (PSMA)-based positron emission tomography (PET) agent, 18F-DCFPyL, to determine the presence or absence of cancer, the accurate distribution of cancer and the normal biodistribution of PSMA in the abdomen and pelvis on PET imaging.
PSMA, also known as folate hydrolase 1 and glutamate carboxypeptidase II, is an enzyme associated with prostate cancer but has been also found to be expressed in the tumor neovasculature of many different types of non-prostate cancer tumors. PSMA-based 18F-DCFPyL PET demonstrates very high tumor-to-background ratio when studied in other tumors, including prostate tumors.
MR imaging is a highly sensitive and specific imaging modality that can be used for gynecologic cancers. MR images can be obtained in conjunction with PSMA PET, adding additional anatomic and multi-parametric MRI information without the need for a second imaging appointment.
Inclusion Criteria for healthy female controls N=12 (includes up to 6 Dosimetry participants):
Inclusion Criteria for female controls (Dosimetry):
Inclusion Criteria for gynecological cancer patients (N=40):
Exclusion Criteria:
The control group will consists of women with no imaging evidence of gynecological cancer, who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=6
Drug: PSMA-based 18F-DCFPyL PET tracer
The patient group will consist of women with suspected gynecological cancers who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive standard of care PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=40
Drug: PSMA-based 18F-DCFPyL PET tracer
Women with or without suspected gynecological cancer. Women will receive PSMA-based 18F-DCFPyL tracer and PET/CT imaging, PET/MR imaging as needed. n=6
Drug: PSMA-based 18F-DCFPyL PET tracer
PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer
Also known as: PSMA
Diagnostic Accuracy
Estimate the frequency with which PSMA PET and MR imaging and final IHC staining disagree in their classifications of presence of disease.
Time frame: up to 1 day
Biodistribution of PSMA Measured by SUVmax in Normal Tissue
Record the normal biodistribution of PSMA as detected in normal tissue controls, by the resulting PET imaging.
Time frame: up to 1 day
Biodistribution of PSMA Measured by SUVmax in Cancer Tissue
Record the biodistribution of PSMA as detected in cancer tissue, by the resulting PET imaging.
Time frame: up to 1 day
Radiodosimetry of PSMA
The radiodosimetry of PSMA-based 18F-DCFPyL will be measured in normal female controls via the resulting PET images.
Time frame: up to 1 day
Sensitivity and Specificity of PSMA-based PET/MR
Record the distribution of PSMA in cancer tissue.
Time frame: up to 1 day
15 participants were consented from November 2017 to December 2019. Research was suspended in March 2020 per the COVID-19 pandemic. The study opened to enrollment again in June 2022; there were no more participants consented. The investigator terminated the study in January 2023 due to slow accrual of patients with ovarian cancer and due to lack of funding. No participants were enrolled in the Dosimetry group.
| Milestone | Healthy Control Non-Dosimetry Group | Patient Group | Dosimetry Group |
|---|---|---|---|
| Started | 2 | 13 | 0 |
| Analysis population | 2 | 12 | 0 |
| Participants with confirmed ovarian cancer with psma uptake | 0 | 1 | 0 |
| Completed | 2 | 12 | 0 |
| Not completed | 0 | 1 | 0 |
| Withdrew: No visible evidence of tumor on mri | 0 | 1 | 0 |
Estimate the frequency with which PSMA PET and MR imaging and final IHC staining disagree in their classifications of presence of disease.
No measurements were reported for this outcome.
Record the normal biodistribution of PSMA as detected in normal tissue controls, by the resulting PET imaging.
| SUVmax | Healthy Control Non-Dosimetry Group | Patient Group | Dosimetry Group |
|---|---|---|---|
| Aorta at carina | 2.0 ± 0.1 | 1.7 ± 0.5 | — |
| Liver - Right Lobe | 12.1 ± 5.4 | 10.0 ± 0.5 | — |
| Myometrium | 2.2 ± 0.4 | 2.9 ± 0.5 | — |
| Endometrium | 5.9 ± 1.8 | 4.8 ± 0.5 | — |
| Cervix | 4.0 ± 1.1 | 3.3 ± 0.5 | — |
| Right Ovary | 1.5 ± 1.7 | 3.0 ± 0.5 | — |
| Corpus Luteum | 6.3 ± NA | 5.9 ± 0.5 | — |
| Left Ovary | 1.7 ± 1.4 | 2.3 ± 0.5 | — |
Record the biodistribution of PSMA as detected in cancer tissue, by the resulting PET imaging.
| SUVmax | Healthy Control Non-Dosimetry Group | Patient Group | Dosimetry Group |
|---|---|---|---|
| Biodistribution of PSMA Measured by SUVmax in Cancer Tissue | — | 10.5 ± NA | — |
The radiodosimetry of PSMA-based 18F-DCFPyL will be measured in normal female controls via the resulting PET images.
No measurements were reported for this outcome.
Record the distribution of PSMA in cancer tissue.
No measurements were reported for this outcome.
Collected over during research visit, up to 3 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Healthy Control Non-Dosimetry Group | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Patient Group | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
study terminated early, no participants enrolled in dosimetry group
| Age, Continuous(years) | Healthy Control Non-Dosimetry Group | Patient Group | Total |
|---|---|---|---|
| Mean | 53.5 (39 to 68) | 57.3 (36 to 86) | 56.7 (36 to 86) |
| Sex: Female, Male(Participants) | Healthy Control Non-Dosimetry Group | Patient Group | Total |
|---|---|---|---|
| Female | 2 | 12 | 14 |
| Male | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Healthy Control Non-Dosimetry Group | Patient Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Healthy Control Non-Dosimetry Group | Patient Group | Total |
|---|---|---|---|
| United States | 2 | 12 | 14 |
| Suspected Participant Diagnosis(Participants) | Healthy Control Non-Dosimetry Group | Patient Group | Total |
|---|---|---|---|
| Healthy Controls | 2 | 0 | 2 |
| Ovarian Cancer | 0 | 8 | 8 |
| Endometrial Cancer | 0 | 3 | 3 |
| Cervical Cancer | 0 | 0 | 0 |
| Other Cancer | 0 | 1 | 1 |
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University of Wisconsin, Madison