PSMA PET and MRI in Gynecological Cancers

NCT03302156 | Terminated Phase 2 Results DMC FDA Drug

• 6 other identifiers: UW170172017-0456A539300SMPH\RADIOLOGY\RADIOLOGYNCI-2018-0046606-08-2020
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Gynecologic Cancer

Keywords

Uterine cancer; Ovarian cancer; Hysterectomy; Salpingo-oophorectomy

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy

  Estimate the frequency with which PSMA PET and MR imaging and final IHC staining disagree in their classifications of presence of disease.

  up to 1 day

Secondary Outcomes (4)

• Biodistribution of PSMA Measured by SUVmax in Normal Tissue

  up to 1 day

• Biodistribution of PSMA Measured by SUVmax in Cancer Tissue

  up to 1 day

• Radiodosimetry of PSMA

  up to 1 day

• Sensitivity and Specificity of PSMA-based PET/MR

  up to 1 day

Study Arms (3)

Healthy Control Non-Dosimetry Group

OTHER

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

Patient Group

OTHER

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

Dosimetry Group

OTHER

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

Interventions

PSMA-based 18F-DCFPyL PET tracer DRUG

PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer

Also known as: PSMA

Dosimetry Group; Healthy Control Non-Dosimetry Group; Patient Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Women with or without suspected gynecological cancer.
• No contraindications for MR or PET imaging.
• Greater than or equal to 18 years of age.
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin, Madison

Madison, Wisconsin, 53705, United States

Location

Related Publications (1)

• Kunikowska 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 DERIVED

Related Links

• University of Wisconsin Carbone Cancer Center

MeSH Terms

Conditions

Uterine Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders

Limitations and Caveats

Calculating accuracy, sensitivity and specificity relies on the IHC staining as the gold standard. IHC staining was not done because the study was terminated due to low recruitment and loss of funds. Because the IHC staining was not performed, there is no gold standard by which to perform accuracy, sensitivity and specificity analysis.

Results Point of Contact

• Title: Elizabeth Sadowski, MD
• Organization: UW School of Medicine and Public Health

esadowski@uwhealth.org

608-263-9028

Study Officials

• Steve Cho, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

• Elizabeth Sadowski, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2017
• First Posted: October 4, 2017
• Study Start: November 15, 2017
• Primary Completion: January 20, 2020
• Study Completion: January 20, 2020
• Last Updated: September 5, 2023
• Results First Posted: August 9, 2023

Record last verified: 2023-07

Locations

US (1)