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[18F]PT2385 PET/CT in Patients With Renal Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04989959
Recruitment Status : Recruiting
First Posted : August 4, 2021
Last Update Posted : May 24, 2023
Sponsor:
Information provided by (Responsible Party):
Orhan Kemal Oz, University of Texas Southwestern Medical Center

Study Description
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Brief 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 three 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. A third cohort will include patients with Von Hippel-Lindau (VHL) syndrome and any of the following disease manifestations - RCC, central nervous system (CNS) hemangioblastoma, and/or pancreatic neuroendocrine tumor(s). Investigational imaging will evaluate HIF2α expression within a tumor type and across different tumor types. A biopsy is encouraged but not mandatory for this cohort.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Clear Cell Renal Cell Carcinoma Drug: [18F]PT2385 Procedure: Positron Emission Tomography/Computed Tomography Procedure: Biopsy Phase 1

Detailed Description:

HIF2α is an emerging therapeutic target in RCC. Proof-of-principle experiments in mice have demonstrated the feasibility of PET/CT imaging with novel radiotracers, [11C] and [18F]PT2385, to assess HIF2α expression in RCC. [18F]PT2385 has been proposed in this study for practical imaging of HIF2α.

This is a non-therapeutic research study. Patients with localized or metastatic RCC will undergo imaging with [18F]PT2385. Patients will have the opportunity to ask questions regarding the procedure. A peripheral intravenous line will be placed for [18F]PT2385 administration. Patients will be injected with [18F]PT2385 intravenously and evaluated by PET/CT.

Up to 20 subjects will undergo a dynamic PET scanning and multi-time point whole body imaging to determine the intratumoral tracer kinetics, the optimal time point for whole body imaging, as well as to calculate human dosimetry. In the first 3 subjects, a dynamic scan over the kidneys will be performed for approximately 25 minutes. Upon completion of the dynamic scan, a whole-body scan will be acquired to yield a whole body distribution at approximately 35 minutes. These 3 subjects will be asked to return for delayed whole body images at 120 and 240 minutes post injection. In up to 7 additional subjects, a dynamic scan will be acquired for 55 minutes followed by an immediate whole body scan to yield whole body distribution at approximately 65 minutes. Additional whole-body images will be acquired at 120 and 240 minutes post-injection.

The pre-surgical cohort of 20 subjects will receive one PET/CT scan at the optimal time point determined from the first 20 subjects. Subsequently, surgery will be performed, and SUV from the PET scans will be correlated with HIF2α levels by IHC on the surgical specimen.

A second cohort of 20 subjects with metastatic RCC will be evaluated. Patients with metastatic disease should all have a previous tissue diagnosis, and this cohort will focus on ccRCC patients. Subjects with metastatic ccRCC will be injected with [18F]PT2385 by intravenous (IV) push and will have a whole-body [18F]PT2385 PET/CT at a time considered optimal based on imaging studies performed in cohort 1. A mandatory biopsy will be performed, and up to 4 suitable core tissue samples will be obtained.

A third cohort of 20 subjects with VHL syndrome and any of the following disease manifestations - RCC, CNS hemangioblastoma, and/or pancreatic neuroendocrine tumor(s)- will be evaluated. Subjects will be injected with [18F]PT2385 by IV push and will have a whole-body [18F]PT2385 PET at a time considered optimal based on imaging studies performed in the cohort 1. A biopsy is encouraged but not mandatory. If pursued, the biopsy will be performed in a similar fashion as that performed in cohort 2. Future biopsies per standard of care may be utilized for HIF2α and/or other biomarker analyses.

Following dosimetry studies, a subset of patients may undergo repeat [18F]PT2385 PET studies.

Patients in all cohorts will receive standard or experimental treatment for RCC at the discretion of the treating physician.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: An Exploratory Study of [18F]PT2385 PET/CT in Patients With Renal Cell Carcinoma
Actual Study Start Date : August 18, 2021
Estimated Primary Completion Date : August 18, 2025
Estimated Study Completion Date : August 18, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Pre-Surgical
Patients with suspected RCC planned for surgery
 Drug: [18F]PT2385
[18F]PT2385 infusion

Procedure: Positron Emission Tomography/Computed Tomography
PET/CT scan after [18F]PT2385 infusion
Other Name: PET/CT
Experimental: Metastatic or VHL Syndrome
Patients with metastatic ccRCC or VHL syndrome and RCC
 Drug: [18F]PT2385
[18F]PT2385 infusion

Procedure: Positron Emission Tomography/Computed Tomography
PET/CT scan after [18F]PT2385 infusion
Other Name: PET/CT

Procedure: Biopsy
CT-guided tumor biopsy
Experimental: Planned belzutifan treatment
Patients with VHL syndrome with RCC, CNS hemangioblastoma, and/or pancreatic neuroendocrine tumor(s) planning to start belzutifan.
 Drug: [18F]PT2385
[18F]PT2385 infusion

Procedure: Positron Emission Tomography/Computed Tomography
PET/CT scan after [18F]PT2385 infusion
Other Name: PET/CT


Outcome Measures
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Primary Outcome Measures :
  1. Correlation between [18F]PT2385 and HIF2α [ Time Frame: Up to 5 years ]
    Correlation between [18F]PT2385 PET avidity and HIF2α expression in primary tumors

  2. Correlation between [18F]PT2385 and HIF2α IHC [ Time Frame: Up to 5 years ]
    Correlation between [18F]PT2385 PET avidity and HIF2α expression by IHC


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to understand and the willingness to sign a written informed consent that includes study interventions (PET/CT and, if cohort 2, mandatory biopsy).
  • Ability to lie still for a 30- to 60-minute PET/CT scan.

  • One of the following:

    1. Cohort 1. Patients with suspected RCC planned for surgery.
    2. Cohort 2. Patients with metastatic ccRCC or VHL syndrome and RCC. Biopsy is required (planned resection for treatment reasons of a metastatic site is acceptable in lieu of the biopsy).
    3. Cohort 3. Patients with VHL syndrome with RCC, CNS hemangioblastoma, and/or pancreatic neuroendocrine tumor(s) planning to start belzutifan.
  • Patients with liver dysfunction will be considered "patients of special interest," and enrollment is allowed with or without criteria outlined for Cohorts 1-3. Liver dysfunction is defined clinically and is typically supported by abnormalities in imaging or laboratory studies (alanine / aspartate amino-transferase, bilirubin, alkaline phosphatase, or international normalized range (INR) for prothrombin time).

  • Women of child-bearing potential must agree to undergo and have documented a negative pregnancy test on the day of [18F]PT2385 administration. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or celibate by choice) who meets the following criteria:

    1. Has not undergone a hysterectomy or bilateral oophorectomy; or
    2. Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

Exclusion Criteria:

  • Uncontrolled severe and irreversible intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
  • Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
  • Claustrophobia or other contraindications to PET/CT.
  • Subjects must not weigh more than the maximum weight limit for the table for the PET/CT scanner where the study is being performed (>200 kilograms or 440 pounds).
  • For cohort 2 patients, lack of suitable sites for mandatory biopsy. For example, patients with metastatic disease restricted to the lungs that would require percutaneous biopsies with associated risk of bleeding and pneumothorax will be excluded.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04989959


Contacts
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Contact: Kelli Key, PhD 214-648-8152 Kelli.Key@UTSouthwestern.edu

Locations
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United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Kelli Key, PhD    214-648-8152    Kelli.Key@UTSouthwestern.edu   
Principal Investigator: James Brugarolas, MD, PhD         
Sponsors and Collaborators
Orhan Kemal Oz
Investigators
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Principal Investigator: James Brugarolas, MD, PhD UT Southwestern Medical Center
More Information
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Responsible Party: Orhan Kemal Oz, Professor and Division Chief, Department of Radiology, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT04989959    
Other Study ID Numbers: STU-2021-0592
First Posted: August 4, 2021    Key Record Dates
Last Update Posted: May 24, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
 Urogenital Neoplasms
Neoplasms by Site
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases