Clear Cell Renal Cell Carcinoma (ccRCC)Phase 2CAIX PET/CTNCT07077083
CAIX PET/CT for Residual or Recurrent Post-ablative ccRCC
A Phase 2 study testing 89Zr-Girentuximab in people with Clear Cell Renal Cell Carcinoma (ccRCC) and ccRCC, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn whether 89Zr-Girentuximab PET scans can inform management of renal cell carcinoma. The main questions it aims to answer are: Does the 89Zr-Girentuximab PET detect ccRCC that is left behind or has come back after treatment? What differences can be seen on the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clear Cell Renal Cell Carcinoma (ccRCC), ccRCC
- What is being tested?
- 89Zr-Girentuximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2026to 1 Aug 2028
- Phase
- Phase 2
- 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
- Written and voluntarily given Informed Consent
- ≥18 years of age at time of consent
- Because no dosing or adverse event data are currently available on the use of 89Zr-girentuximab in participants <18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.
- Have the capacity to understand the study and be willing and able to comply with all protocol requirements.
- Findings suspicious for post-ablation residual or recurrent ccRCC (subjects in cohort 1) documented at conventional imaging or biopsy, performed within 90 days prior to 89Zr-girentuximab PET scan.
- Findings suspicious for primary ccRCC (subjects in cohort 2) documented at standard histology or conventional imaging, performed within 90 days prior to 89Zr-girentuximab PET scan.
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- Negative serum or urine pregnancy tests in female patients of childbearing potential within 72 hours prior to receiving 89Zr-girentuximab. Female patients of non-child bearing potential must provide evidence by fulfilling one of the following criteria at screening:
- Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments
- Women under 50 years old would be consider postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range for the institution
- Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation
- For all participants, consent to practice double-barrier contraception until a minimum of 42 days after 89Zr-girentuximab administration.
Who cannot join
- Renal mass known to be a metastasis of another primary tumor.
- Active non-renal malignancy requiring therapy during and up to EOT visit.
- Planned antineoplastic therapies (for the period between IV administration of 89Zr-girentuximab and imaging).
- Previous administration of any radionuclide within 10 of its half-lives before 89Zr-girentuximab injection day.
- Serious non-malignant disease (e.g., psychiatric, infectious, autoimmune, or metabolic), that may interfere with the objectives of the program or with the safety or compliance of the subject, as judged by the Investigator.
- Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the program.
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- Women who are pregnant or breastfeeding.
- Known hypersensitivity to girentuximab or DFO (desferoxamine).
- Renal insufficiency with estimated glomerular filtration rate eGFR ≤ 40 mL/min/ 1.73 m²
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
Massachusetts General Hospital
Boston, Massachusetts, 02114
Taylor McVeigh, 6177261312, tmcveigh@mgh.harvard.edu
Shadi Abdar Esfahani, MD, MPH
About this study
Official title: A Pilot Study of 89Zr-girentuximab for PET Imaging in Residual or Recurrent Post Ablative Tumors in Patients With Renal Cell Carcinoma.
The goal of this clinical trial is to learn whether 89Zr-Girentuximab PET scans can inform management of renal cell carcinoma. The main questions it aims to answer are:
- Does the 89Zr-Girentuximab PET detect ccRCC that is left behind or has come back after treatment?
- What differences can be seen on the 89Zr-Girentuximab PET before and after standard of care treatment?
Participants in arm 1 will be given the study drug followed by a PET scan 3-7 days after injection. Participants in arm 2 will receive the same, but will proceed with their standard of care cryoablation after the initial PET scan. Within 3 days of the cryoablation treatment, participants will receive a repeat PET scan.
- Conditions
- Clear Cell Renal Cell Carcinoma (ccRCC), ccRCC
- Being tested
- 89Zr-Girentuximab
- Keywords
- kidney, kidney cancer, imaging
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-GirentuximabDrug
89Zr-Girentuximab PET
| Study group | Role | What they receive |
|---|---|---|
| Patients with known or suspected recurrent or residual ccRCC | Experimental | PET and Histological correlation Receives: Drug: 89Zr-Girentuximab |
| Patients with ccRCC undergoing ablation | Experimental | PET for evaluation of post-ablative kidney Receives: Drug: 89Zr-Girentuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUVmean of the ablated zone and adjacent or contralateral uninvolved kidney
Qualitative and quantitative assessment of 89Zr-girentuximab probe uptake of the ablative zone in the kidney will be performed. Guided by the findings of standard CT or MRI, a region of interest (ROI) will be drawn over the ablation zone and adjacent uninvolved kidney. SUVmean of the ROIs will be measured for the recurrent/residual tumor and the adjacent or contralateral normal kidney. Descriptive statistics including the mean SUVmean and standard deviation will be reported for each ROI. Tumor to kidney uptake ratio will also be calculated. It is expected that the recurrent/residual tumor will show uptake above the uninvolved kidney.
Measured: From enrollment to 0-3 days after SOC cryoablation
SUVmax of the ablated zone and adjacent or contralateral uninvolved kidney
Qualitative and quantitative assessment of 89Zr-girentuximab probe uptake of the ablative zone in the kidney will be performed. Guided by the findings of standard CT or MRI, a region of interest (ROI) will be drawn over the ablation zone and adjacent uninvolved kidney. SUVmax of the ROIs will be measured for the recurrent/residual tumor and the adjacent or contralateral normal kidney. Descriptive statistics including the SUVmax and standard deviation will be reported for each ROI. Tumor to kidney uptake ratio will also be calculated. It is expected that the recurrent/residual tumor will show uptake above the uninvolved kidney.
Measured: From enrollment to 0-3 days after SOC cryoablation
Secondary outcomes (2)
Comparison of SUVmean on pre- and post-ablation scans
Guided by the standard CT or MRI, an ROI will be defined over the primary kidney tumor and adjacent uninvolved kidney on the scans before and after cryoablation. SUVmean as well as tumor to kidney ratio will be calculated on the pre- and post-ablation scans to evaluate whether the uptake decreases immediately after ablation.
Measured: Baseline through 0-3 days days after SOC cryoablation
Comparison of SUVmax on pre- and post-ablation scans
Guided by the standard CT or MRI, an ROI will be defined over the primary kidney tumor and adjacent uninvolved kidney on the scans before and after cryoablation. SUVmax as well as tumor to kidney ratio will be calculated on the pre- and post-ablation scans to evaluate whether the uptake decreases immediately after ablation.
Measured: Baseline through 0-3 days after SOC cryoablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start16 Sep 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clear Cell Renal Cell Carcinoma (ccRCC)Studies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Telix Pharmaceuticals (Innovations) Pty Ltd
- Responsible party
- Principal investigator, Shadi Abdar Esfahani, Massachusetts General Hospital
- Investigators
- Shadi Abdar Esfahani, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077083
- Sponsor's protocol ID
- 25-240
- Acronym
- CAIX PET/CT
- Status last verified
- Jul 2026
- First submitted
- 24 Jun 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The information on patient demographics, cancer (ccRCC) history, imaging findings, and histological assessment will be shared in scientific presentations and publications.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of 89Zr-girentuximab for PET Imaging in Residual or Recurrent Post Ablative Tumors in Patients With Renal Cell Carcinoma.
- ClinicalTrials.gov ID
- NCT07077083
- Acronym / sponsor ID
- CAIX PET/CT / 25-240
- Conditions
- Clear Cell Renal Cell Carcinoma (ccRCC), ccRCC
- Keywords
- kidney, kidney cancer, imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Telix Pharmaceuticals (Innovations) Pty Ltd
- Study start
- 16 Sep 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 22 Jul 2025 (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.
The goal of this clinical trial is to learn whether 89Zr-Girentuximab PET scans can inform management of renal cell carcinoma. The main questions it aims to answer are:
- Does the 89Zr-Girentuximab PET detect ccRCC that is left behind or has come back after treatment?
- What differences can be seen on the 89Zr-Girentuximab PET before and after standard of care treatment?
Participants in arm 1 will be given the study drug followed by a PET scan 3-7 days after injection. Participants in arm 2 will receive the same, but will proceed with their standard of care cryoablation after the initial PET scan. Within 3 days of the cryoablation treatment, participants will receive a repeat PET scan.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with known or suspected recurrent or residual ccRCC | Experimental | Drug: 89Zr-GirentuximabPET and Histological correlation |
| Patients with ccRCC undergoing ablation | Experimental | Drug: 89Zr-GirentuximabPET for evaluation of post-ablative kidney |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written and voluntarily given Informed Consent
- ≥18 years of age at time of consent
- Have the capacity to understand the study and be willing and able to comply with all protocol requirements.
- Findings suspicious for post-ablation residual or recurrent ccRCC (subjects in cohort 1) documented at conventional imaging or biopsy, performed within 90 days prior to 89Zr-girentuximab PET scan.
- Findings suspicious for primary ccRCC (subjects in cohort 2) documented at standard histology or conventional imaging, performed within 90 days prior to 89Zr-girentuximab PET scan.
Key exclusion criteria (9 listed)
- Renal mass known to be a metastasis of another primary tumor.
- Active non-renal malignancy requiring therapy during and up to EOT visit.
- Planned antineoplastic therapies (for the period between IV administration of 89Zr-girentuximab and imaging).
- Previous administration of any radionuclide within 10 of its half-lives before 89Zr-girentuximab injection day.
- Serious non-malignant disease (e.g., psychiatric, infectious, autoimmune, or metabolic), that may interfere with the objectives of the program or with the safety or compliance of the subject, as judged by the Investigator.
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 |
|---|---|---|
| 89Zr-Girentuximab89Zr-Girentuximab PET | Drug | Patients with ccRCC undergoing ablation, Patients with known or suspected recurrent or residual ccRCC |
Primary outcome
SUVmean of the ablated zone and adjacent or contralateral uninvolved kidney
Time frame: From enrollment to 0-3 days after SOC cryoablation
Qualitative and quantitative assessment of 89Zr-girentuximab probe uptake of the ablative zone in the kidney will be performed. Guided by the findings of standard CT or MRI, a region of interest (ROI) will be drawn over the ablation zone and adjacent uninvolved kidney. SUVmean of the ROIs will be measured for the recurrent/residual tumor and the adjacent or contralateral normal kidney. Descriptive statistics including the mean SUVmean and standard deviation will be reported for each ROI. Tumor to kidney uptake ratio will also be calculated. It is expected that the recurrent/residual tumor will show uptake above the uninvolved kidney.
SUVmax of the ablated zone and adjacent or contralateral uninvolved kidney
Time frame: From enrollment to 0-3 days after SOC cryoablation
Qualitative and quantitative assessment of 89Zr-girentuximab probe uptake of the ablative zone in the kidney will be performed. Guided by the findings of standard CT or MRI, a region of interest (ROI) will be drawn over the ablation zone and adjacent uninvolved kidney. SUVmax of the ROIs will be measured for the recurrent/residual tumor and the adjacent or contralateral normal kidney. Descriptive statistics including the SUVmax and standard deviation will be reported for each ROI. Tumor to kidney uptake ratio will also be calculated. It is expected that the recurrent/residual tumor will show uptake above the uninvolved kidney.
2 secondary outcomes
Comparison of SUVmean on pre- and post-ablation scans
Time frame: Baseline through 0-3 days days after SOC cryoablation
Comparison of SUVmax on pre- and post-ablation scans
Time frame: Baseline through 0-3 days after SOC cryoablation
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 21 Jul 2026.
- Individual participant dataSharing planned: Yes. The information on patient demographics, cancer (ccRCC) history, imaging findings, and histological assessment will be shared in scientific presentations and publications.
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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.
Shadi Abdar Esfahani, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 89Zr-Girentuximab in people with Clear Cell Renal Cell Carcinoma (ccRCC) and ccRCC, run by Massachusetts General Hospital 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 11 inclusion and 9 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: opening soon, as of the sponsor's last update on 21 Jul 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Taylor McVeigh (6177261312, tmcveigh@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUVmean of the ablated zone and adjacent or contralateral uninvolved kidney (time frame: From enrollment to 0-3 days after SOC cryoablation). 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 21 Jul 2026; AzTrials last refreshed its copy on 31 Oct 2026.