[18F]PT2385 PET/CT in Patients With Renal Cell Carcinoma
Status:
Recruiting
Trial end date:
2026-08-18
Target enrollment:
Participant gender:
Summary
This is an exploratory study to assess [18F]PT2385 Positron Emission Tomography/Computed
Tomography (PET/CT) in patients with renal cell carcinoma (RCC). This is an open-label,
nontherapeutic trial. The main objective is to correlate hypoxia-inducible factor-2alpha
(HIF2α) levels as determined by an investigational [18F]PT2385 PET/CT scan with the levels on
subsequently obtained tissue by HIF2α immunohistochemistry (IHC). There will be two cohorts.
The first pre-surgical cohort will have [18F]PT2385 PET/CT prior to nephrectomy. The uptake
and retention on Positron Emission Tomography (PET), quantified as standardized uptake value
(SUV) max and mean, abbreviated SUV henceforth will be correlated with HIF2α levels by IHC on
the primary tumor. The second cohort will comprise patients with metastatic clear cell renal
carcinoma (ccRCC). SUV will be correlated with HIF2α levels measured by IHC on a biopsy
sample from a metastasis. Both low- and high-avidity sites will be biopsied and tracer uptake
correlated with HIF2α IHC.