Renal Cell CarcinomaPhase 1NCT04989959
[18F]PT2385 PET/CT in Patients With Renal Cell Carcinoma
A Phase 1 study testing [18F]PT2385, Positron Emission Tomography/Computed Tomography and Biopsy in people with Renal Cell Carcinoma and Clear Cell Renal Cell Carcinoma, run by Orhan Kemal Oz at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma, Clear Cell Renal Cell Carcinoma
- What is being tested?
- [18F]PT2385, Positron Emission Tomography/Computed Tomography and Biopsy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2021to 18 Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Cohort 1. Patients with suspected RCC planned for surgery.
- 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).
- Cohort 3. Patients with VHL syndrome with RCC, CNS hemangioblastoma, and/or pancreatic neuroendocrine tumor(s) planning to start belzutifan.
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- 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:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Kelli Key, PhD, 214-648-8152, Kelli.Key@UTSouthwestern.edu
James Brugarolas, MD, PhD
About this study
Official title: An Exploratory Study of [18F]PT2385 PET/CT in Patients With Renal Cell Carcinoma
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.
Read the 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 15 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 5 subjects will receive one PET/CT scan at the optimal time point determined from the first 15 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 10 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 5 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.
Recently available at UTSW, Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI) may be used instead of PET/CT at the physician/investigator discretion wherever PET/CT is mentioned. PET/MRI is a novel hybrid technology that combines physiologic information from a PET scan and detailed anatomic images from an magnetic resonance imaging (MRI) scan. PET/MRI has the potential to increase imaging quality/diagnostic accuracy while reducing radiation exposure.
- Being tested
- [18F]PT2385, Positron Emission Tomography/Computed Tomography, Biopsy
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]PT2385Drug
[18F]PT2385 infusion
Positron Emission Tomography/Computed TomographyProcedure or surgery
Also called PET/CT
PET/CT scan after [18F]PT2385 infusion
BiopsyProcedure or surgery
CT-guided tumor biopsy
| Study group | Role | What they receive |
|---|---|---|
| Pre-Surgical | Experimental | Patients with suspected RCC planned for surgery Receives: Drug: [18F]PT2385; Procedure: Positron Emission Tomography/Computed Tomography |
| Metastatic or VHL Syndrome | Experimental | Patients with metastatic ccRCC or VHL syndrome and RCC Receives: Drug: [18F]PT2385; Procedure: Positron Emission Tomography/Computed Tomography; Procedure: Biopsy |
| Planned belzutifan treatment | Experimental | Patients with VHL syndrome with RCC, CNS hemangioblastoma, and/or pancreatic neuroendocrine tumor(s) planning to start belzutifan. Receives: Drug: [18F]PT2385; Procedure: Positron Emission Tomography/Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between [18F]PT2385 and HIF2α
Correlation between [18F]PT2385 PET avidity and HIF2α expression in primary tumors
Measured: Up to 5 years
Correlation between [18F]PT2385 and HIF2α IHC
Correlation between [18F]PT2385 PET avidity and HIF2α expression by IHC
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start18 Aug 2021
- Primary completion18 Aug 2026 (estimated)
- Study completion18 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orhan Kemal Oz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Orhan Kemal Oz, University of Texas Southwestern Medical Center
- Investigators
- James Brugarolas, MD, PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989959
- Sponsor's protocol ID
- STU-2021-0592
- Status last verified
- Nov 2025
- First submitted
- 27 Jul 2021
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of [18F]PT2385 PET/CT in Patients With Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04989959
- Acronym / sponsor ID
- STU-2021-0592
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Orhan Kemal OzUniversity, hospital or other
- Study start
- 18 Aug 2021 (actual)
- Primary completion
- 18 Aug 2026 (estimated)
- Study completion
- 18 Aug 2027 (estimated)
- First posted
- 4 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 15 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 5 subjects will receive one PET/CT scan at the optimal time point determined from the first 15 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 10 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 5 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.
Recently available at UTSW, Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI) may be used instead of PET/CT at the physician/investigator discretion wherever PET/CT is mentioned. PET/MRI is a novel hybrid technology that combines physiologic information from a PET scan and detailed anatomic images from an magnetic resonance imaging (MRI) scan. PET/MRI has the potential to increase imaging quality/diagnostic accuracy while reducing radiation exposure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre-Surgical | Experimental | Drug: [18F]PT2385, Procedure: Positron Emission Tomography/Computed TomographyPatients with suspected RCC planned for surgery |
| Metastatic or VHL Syndrome | Experimental | Drug: [18F]PT2385, Procedure: Positron Emission Tomography/Computed Tomography, Procedure: BiopsyPatients with metastatic ccRCC or VHL syndrome and RCC |
| Planned belzutifan treatment | Experimental | Drug: [18F]PT2385, Procedure: Positron Emission Tomography/Computed TomographyPatients with VHL syndrome with RCC, CNS hemangioblastoma, and/or pancreatic neuroendocrine tumor(s) planning to start belzutifan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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:
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]PT2385[18F]PT2385 infusion | Drug | Metastatic or VHL Syndrome, Planned belzutifan treatment, Pre-Surgical |
| Positron Emission Tomography/Computed TomographyAlso: PET/CTPET/CT scan after [18F]PT2385 infusion | Procedure or surgery | Metastatic or VHL Syndrome, Planned belzutifan treatment, Pre-Surgical |
| BiopsyCT-guided tumor biopsy | Procedure or surgery | Metastatic or VHL Syndrome |
Primary outcome
Correlation between [18F]PT2385 and HIF2α
Time frame: Up to 5 years
Correlation between [18F]PT2385 PET avidity and HIF2α expression in primary tumors
Correlation between [18F]PT2385 and HIF2α IHC
Time frame: Up to 5 years
Correlation between [18F]PT2385 PET avidity and HIF2α expression by IHC
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James Brugarolas, MD, PhD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [18F]PT2385, Positron Emission Tomography/Computed Tomography and Biopsy in people with Renal Cell Carcinoma and Clear Cell Renal Cell Carcinoma, run by Orhan Kemal Oz at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelli Key, PhD (214-648-8152, Kelli.Key@UTSouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between [18F]PT2385 and HIF2α (time frame: Up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.