Recruiting
Early Phase 1

[18F] PSMA-1007

Sponsor:

Western University

Code:

NCT06428708

Conditions

Metastatic Clear Cell Renal Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

[18F] PSMA-1007 PET/CT

Study Details

Brief summary:

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.

Conditions

Metastatic Clear Cell Renal Cell Carcinoma

Study ID

NCT06428708

Start date

Jan 24, 2022

Status verified date

Jun, 2024

Completion date

Sep, 2025

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: [18F] PSMA-1007 PET/CT

All patients enrolled undergo a \[18F\] PSMA-1007 PET/CT

Interventions

[18F] PSMA-1007 PET/CT

\[18F\] PSMA-1007 PET/CT scan

Primary outcome measure

  • Number of metastatic lesions [ Time Frame: 5 weeks from initial baseline conventional imaging ]
  • Change in management [ Time Frame: 1 month ]

Central Contacts and Locations

Central contacts

Kaydee Connors

519-685-8500kaydee.connors@lhsc.on.ca

Nicole Phillips

519-685-8500nicole.phillips@lhsc.on.ca

Locations

London Health Sciences Centre - Victoria Hospital

Recruiting

London, Ontario, Canada, N6A5W9

Contacts

Kaydee Connors

519-685-6366kaydee.connors@lhsc.on.ca

Nicole Phillips

519-685-6366Nicole.Phillips@lhsc.on.ca

Principal Investigator:

Melissa Huynh, MD

More Information

Sponsor

Western University

Last update posted

Jun 25, 2024

Last verified

Jun, 2024

Keywords

  • PSMA PET
  • Metastatic clear cell renal cell carcinoma
  • [18F]PSMA-1007
  • PSMA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Western University on 2024-06-25.