To hear about similar clinical trials, please enter your email below
Trial Title:
[18F] PSMA-1007 PET/CT in Metastatic Clear Cell Renal Cell Carcinoma
NCT ID:
NCT06428708
Condition:
Metastatic Clear Cell Renal Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Conditions: Keywords:
PSMA PET
Metastatic clear cell renal cell carcinoma
[18F]PSMA-1007
PSMA
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
[18F] PSMA-1007 PET/CT
Description:
[18F] PSMA-1007 PET/CT scan
Arm group label:
[18F] PSMA-1007 PET/CT
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.
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.
Criteria for eligibility:
Criteria:
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
London Health Sciences Centre - Victoria Hospital
Address:
City:
London
Zip:
N6A5W9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Kaydee Connors
Phone:
519-685-6366
Email:
kaydee.connors@lhsc.on.ca
Contact backup:
Last name:
Nicole Phillips
Phone:
519-685-6366
Email:
Nicole.Phillips@lhsc.on.ca
Investigator:
Last name:
Melissa Huynh, MD
Email:
Principal Investigator
Start date:
January 24, 2022
Completion date:
September 2025
Lead sponsor:
Agency:
Western University
Agency class:
Other
Source:
Western University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06428708
