Clinical trial · Interventional
PSMA PET and MRI in Gynecological Cancers
PSMA Positron Emission Tomography (PET) and Magnetic Resonance (MR) Imaging in Gynecological Cancers
NCT03302156CI-TRIAL-00069318terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual following suspension per COVID-19
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PSMA-based 18F-DCFPyL PET tracer | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- Healthy Control Non-Dosimetry Group
- description
- 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
- interventionNames
- Drug: PSMA-based 18F-DCFPyL PET tracer
- type
- OTHER
- label
- Patient Group
- description
- 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
- interventionNames
- Drug: PSMA-based 18F-DCFPyL PET tracer
- type
- OTHER
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria for healthy female controls N=12 (includes up to 6 Dosimetry participants): * Women with no suspected gynecological cancer. * No contraindications for MR or PET imaging. * Greater than or equal to 18 years of age. * Scheduled to undergo a hysterectomy and/or salpingo-oophorectomy Inclusion Criteria for female controls (Dosimetry): * Women with or without suspected gynecological cancer. * No contraindications for MR or PET imaging. * Greater than or equal to 18 years of age. Inclusion Criteria for gynecological cancer patients (N=40): * Women with known or suspected gynecological cancer * No contraindications for MR or PET imaging. * Greater than or equal to 18 years * Have had or are scheduled to undergo a hysterectomy and/or salpingo-oophorectomy Exclusion Criteria: * Women that are pregnant or breast-feeding. * Age \<18 * Inability to provide informed consent on their own behalf * Severe kidney dysfunction (GFR \<30 mL/min/1.73m2)
References
Publications (1)
- DERIVEDKunikowska J, Bizon M, Pelka K, Derlatka P, Olszewski M, Krolicki L. 68 Ga-Prostate-Specific Membrane Antigen PET/CT in Ovarian Tumors : Potential to Differentiate Benign and Malignant Tumors Before Surgery: A Preliminary Report. Clin Nucl Med. 2023 Feb 1;48(2):e60-e66. doi: 10.1097/RLU.0000000000004486. Epub 2022 Nov 18. PMID 36512649