[18F] PSMA-1007 PET/CT in Metastatic Clear Cell Renal Cell Carcinoma

June 22, 2024 updated by: Melissa Huynh, Western University

Comparison of [18F] PSMA-1007 PET/CT and Conventional Imaging in the Detection of Metastatic Clear Cell Renal Cell Carcinoma

Staging of kidney cancer is primarily achieved by computerized tomography (CT) scans or magnetic resonance imaging (MRI). If a patient is found to have limited metastatic disease, surgical removal or radiation therapy could be considered in order to control the majority of the disease. However, if metastases are more widespread, systemic (drug) therapy may be the preferred management option. The identification of additional metastatic sites using more sensitive imaging modalities therefore has the potential to alter management, and this remains an unmet need in the field. This study will investigate the utility of positron emission tomography (PET) imaging with PSMA (prostate specific membrane antigen). Kidney cancer of the clear cell subtype has demonstrated high expression of PSMA, making it a disease in which PSMA-targeted PET imaging could help to identify occult metastatic disease.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This will be a single-institution prospective, open-label feasibility study involving patients ≥18 years of age with metastatic clear cell RCC who have not yet received systemic therapy. Patients with evidence of metastatic disease on conventional imaging will require histologic confirmation by biopsy. At our institution, approximately 26 new metastatic clear cell RCC (mRCC) patients are seen each year, and a previous analysis reported that 92% of 10,105 patients with mRCC in the International mRCC Database Consortium (IMDC) database were found to have clear cell histology; therefore, difficulty with recruitment into this study over a period of 2 years is not anticipated.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A5W9
        • Recruiting
        • London Health Sciences Centre - Victoria Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Melissa Huynh, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Men and women with histologically-proven, metastatic renal cell carcinoma (RCC)(TNM stage Tany, Nany, M1)
  2. Must have baseline conventional imaging of the chest, abdomen, and pelvis with contrast-enhanced CT or MRI within 5 weeks of enrolment. Contrast is required unless the participant cannot for medical reasons (ie renal failure).

Exception: Unenhanced CT of the chest is acceptable Exception: Unenhanced MRI of abdomen and pelvis is acceptable in cases of renal failure

Exclusion Criteria:

  1. Pregnant or breastfeeding
  2. Age less than 18
  3. Histology does not have any clear cell component
  4. Unable to lie flat for 30 minutes for the scan
  5. History of prior malignancy (except non-melanoma skin cancer)
  6. Unable to provide informed consent
  7. Inadequate liver function
  8. Systemic or radiation-based cancer treatment is needed urgently and anticipated to begin before PSMA scan can take place
  9. Previously exposed to systemic or radiation cancer therapy (except radiation for skin cancer)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: [18F] PSMA-1007 PET/CT
All patients enrolled undergo a [18F] PSMA-1007 PET/CT
Diagnostic test: [18F] PSMA-1007 PET/CT
[18F] PSMA-1007 PET/CT scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of metastatic lesions
Time Frame: 5 weeks from initial baseline conventional imaging
To identify additional metastatic lesions that may not be apparent on conventional cross-sectional imaging during the initial staging process.
5 weeks from initial baseline conventional imaging
Change in management
Time Frame: 1 month
To determine the proportion of patients in which results from the PSMA-PET imaging changes management.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathologic correlates
Time Frame: 1 month or not applicable
To determine histopathological correlation in lesions that are biopsied or removed surgically.
1 month or not applicable

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western University

Investigators

  • Principal Investigator: Melissa Huynh, MD, Western University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2022

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

May 20, 2024

First Submitted That Met QC Criteria

May 20, 2024

First Posted (Actual)

May 24, 2024

Study Record Updates

Last Update Posted (Actual)

June 25, 2024

Last Update Submitted That Met QC Criteria

June 22, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ReDA 11465

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metastatic Clear Cell Renal Cell Carcinoma

Clinical Trials on [18F] PSMA-1007 PET/CT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe