Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
ID06428708

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

Led by Western University · Updated on 2024-06-25

30

Participants Needed

1

Research Sites

39 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of a new imaging technique called [18F] PSMA-1007 PET/CT to detect metastatic clear cell renal cell carcinoma, a type of kidney cancer. This study focuses on patients 18 years or older who have metastatic clear cell kidney cancer and have not yet received systemic therapy. The goal is to see if this PET imaging can identify additional metastatic sites that conventional CT or MRI scans might miss, potentially changing how the disease is managed. All participants will undergo a single [18F] PSMA-1007 PET/CT scan to evaluate metastatic cancer lesions. This is a prospective, open-label study conducted at a single institution. Participants must have baseline conventional imaging of the chest, abdomen, and pelvis within 5 weeks before enrollment. The study will compare the PET/CT results to those of conventional imaging to assess the number of metastatic lesions and any changes in treatment plans. During the study, participants will have their imaging results reviewed, and any necessary histologic confirmation by biopsy will be performed if metastatic disease is found on conventional imaging. Researchers will monitor the number of detected metastatic lesions and any changes in patient management within one month. Pathologic correlates will also be assessed when applicable. The study expects to follow patients until September 2025, with careful safety and outcome monitoring throughout the process.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women with biopsy-confirmed metastatic renal cell carcinoma including any T, N, and M1 stages
  • Baseline contrast-enhanced CT or MRI of chest, abdomen, and pelvis within 5 weeks before enrollment (unenhanced imaging accepted in renal failure cases)
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding individuals
  • Age under 18 years
  • Kidney cancer without a clear cell component
  • Unable to lie flat for 30 minutes for the scan
  • History of previous cancer except for non-melanoma skin cancer
  • Unable to provide informed consent
  • Inadequate liver function
  • Need for urgent systemic or radiation cancer treatment before the PSMA scan
  • Prior systemic or radiation cancer therapy except for skin cancer radiation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - Up to 5 weeks before enrollment

Participants are screened for eligibility to participate in the trial.

1 screening visit (in-person)

Diagnostic Evaluation

Duration - Single day

Participants undergo a [18F] PSMA-1007 PET/CT scan to detect metastatic clear cell renal cell carcinoma.

1 visit for PET/CT scan (in-person)

Long-term Monitoring

Duration - Up to 1 month

Participants are monitored for changes in management and pathologic correlates following the imaging procedure.

Follow-up assessments up to 1 month after imaging

Trial Site Locations

Total: 1 location

1

London Health Sciences Centre - Victoria Hospital

London, Ontario, Canada, N6A5W9

Actively Recruiting

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Research Team

K

Kaydee Connors

N

Nicole Phillips

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Published Research Related To This Trial

18F-PSMA-1007 PET/CT for response assessment in patients with metastatic renal cell carcinoma undergoing tyrosine kinase or checkpoint inhibitor therapy: preliminary results.

L M Mittlmeier, M Unterrainer, S Rodler...

https://pubmed.ncbi.nlm.nih.gov/33369689

F-18 labelled PSMA-1007: biodistribution, radiation dosimetry and histopathological validation of tumor lesions in prostate cancer patients.

Frederik L Giesel, B Hadaschik, J Cardinale...

https://pubmed.ncbi.nlm.nih.gov/27889802

Inconsistent Detection of Sites of Metastatic Non-Clear Cell Renal Cell Carcinoma with PSMA-Targeted [18F]DCFPyL PET/CT.

Yafu Yin, Scott P Campbell, Mark C Markowski...

https://pubmed.ncbi.nlm.nih.gov/30218388

Improved identification of patients with oligometastatic clear cell renal cell carcinoma with PSMA-targeted 18F-DCFPyL PET/CT.

Alexa R Meyer, Michael A Carducci, Samuel R Denmeade...

https://pubmed.ncbi.nlm.nih.gov/31147927

Biodistribution of [(68)Ga]PSMA-HBED-CC in Patients with Prostate Cancer: Characterization of Uptake in Normal Organs and Tumour Lesions.

Vikas Prasad, Ingo G Steffen, Gerd Diederichs...

https://pubmed.ncbi.nlm.nih.gov/27038316

Significance of 18F-fluorodeoxyglucose positron-emission tomography/computed tomography for the postoperative surveillance of advanced renal cell carcinoma.

Jong Wook Park, Moon Ki Jo, Hyun Moo Lee

https://pubmed.ncbi.nlm.nih.gov/19007371