Metastatic Clear Cell Renal Cell CarcinomaPhase 2NCT05879471
68Ga-NY104 PET/CT in Patients With Metastatic Clear Cell Renal Cell Carcinoma
A Phase 2 study testing 68Ga-NY104 PET/CT in people with Metastatic Clear Cell Renal Cell Carcinoma, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is a prospective, single-center, single-arm, comparative phase 2 study in patients with metastatic clear cell renal cell carcinoma. The goal is to determine the sensitivity of 68Ga-NY104 PET/CT in patients with metastatic clear cell renal cell carcinoma and compare it with 18F-FDG PET/CT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Clear Cell Renal Cell Carcinoma
- What is being tested?
- 68Ga-NY104 PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 1 Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Age ≥ 18 y
- Histopathological diagnosis of clear cell renal cell carcinoma
- Metastatic disease confirmed by histopathology or typical appearance of multifocal metastatic disease
- Expected survival of at least 6 months
- ECOG ≤ 2
- Written informed consent provided for participation in the trial
- In the opinion of investigator, willing and able to comply with required study procedures.
Who cannot join
- On VEGF TKI treatment less than 1 week before 68Ga-NY104 PET/CT. TKI is known to affect girentuximab binding in patients with ccRCC and is expected to have the same effect on 68Ga-NY104. If patients were on VEGF TKI treatment, such as sunitinib, sorafenib, cabozantinib, pazopanib, or lenvatinib, a washout of one week before 68Ga-NY104 PET/CT is required.
- Patients on HIF antagonist treatment < 3 months before 68Ga-NY104 PET/CT. CA9, which encodes carbonic anhydrase IX (CAIX), is one of the genes most strongly upregulated by HIF-1. HIF antagonist, such as Belzutifan, might affect the expression of CAIX and thus the binding of 68Ga-NY104 to tumor. Withdraw of at least 3 months is required for HIF antagonist.
- Pregnancy or breastfeeding.
- Severe claustrophobia.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Wenjia Zhu, MD, zhuwenjia_pumc@163.com
About this study
Official title: 68Ga-NY104 PET/CT and 18F-FDG PET/CT in Patients With Metastatic Clear Cell Renal Cell Carcinoma: a Prospective, Single Center, Single Arm, Comparative Imaging Trial
This is a prospective, single-center, single-arm, comparative phase 2 study in patients with metastatic clear cell renal cell carcinoma. The goal is to determine the sensitivity of 68Ga-NY104 PET/CT in patients with metastatic clear cell renal cell carcinoma and compare it with 18F-FDG PET/CT.
Read the detailed description
This is a prospective, single-center, single-arm, comparative phase 2 study in patients with metastatic clear cell renal cell carcinoma. Each patient will receive one dose of 68Ga-NY104 and one dose of 18F-FDG by intravenous route. Dedicated whole-body PET/CT imaging will be performed. PET/CT studies will be interpreted by two readers, both of whom will provide independent, blinded interpretations. Imaging interpretations and a composite reference standard will be used to estimate the sensitivity of each modality. The tumor uptake will also be compared for matched lesions.
39 patients will be recruited in Peking Union Medical College Hospital.
- Being tested
- 68Ga-NY104 PET/CT
- Keywords
- 68Ga-NY104, PET/CT, Clear Cell Renal Cell Carcinoma
- Medical subject headings
- Clear-cell metastatic renal cell carcinoma, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-NY104 PET/CTDiagnostic test
Also called 68Ga-NYM005 PET/CT
Participants will be administered a single, intravenous bolus of 68Ga-NY104 The recommended administered activity of 68Ga-NY104 is 1.8-2.2 MBq per kilogram bodyweight, subject to variation that may be required owing to variable elution efficiencies obtained during the lifetime of the 68Ga / 68Ga generator The CT and PET imaging session will begin approximately 45 to 75 minutes after 68Ga-NY104 administration.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-NY104 PET/CT | Experimental | Each patient will receive one dose of 68Ga-NY104 by intravenous route. Dedicated whole-body PET/CT imaging will be performed. Receives: Diagnostic Test: 68Ga-NY104 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positivity of lesions detected by 68Ga-NY104 PET
Any focal accumulation that cannot be explained by physiologic uptake of the 68Ga-NY104 will be interpreted as focal lesion.
Measured: From study completion to 1 month after completion
Positivity of lesions detected by 18F-FDG PET
Any focal accumulation that cannot be explained by physiologic uptake of 18F-FDG will be interpreted as focal lesion.
Measured: From study completion to 1 month after completion
Secondary outcomes (2)
SUVmax of lesions detected by 68Ga-NY104 PET
The tracer uptake in focal lesions is quantified using maximal standard uptake value (SUVmax) by drawing a 3-dimentional region of interest (ROI) over the lesion using a threshold of 40% SUVmax.
Measured: From study completion to 1 month after completion
SUVmax of lesions detected by 18F-FDG PET
The tracer uptake in focal lesions is quantified using maximal standard uptake value (SUVmax) by drawing a 3-dimentional region of interest (ROI) over the lesion using a threshold of 40% SUVmax.
Measured: From study completion to 1 month after completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Clear Cell Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Huo, MD, Principal investigator, Peking Uion Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879471
- Sponsor's protocol ID
- NYCRM
- Status last verified
- Jul 2023
- First submitted
- 18 May 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Available upon request
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 68Ga-NY104 PET/CT and 18F-FDG PET/CT in Patients With Metastatic Clear Cell Renal Cell Carcinoma: a Prospective, Single Center, Single Arm, Comparative Imaging Trial
- ClinicalTrials.gov ID
- NCT05879471
- Acronym / sponsor ID
- NYCRM
- Keywords
- 68Ga-NY104, PET/CT, Clear Cell Renal Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 30 May 2023 (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 a prospective, single-center, single-arm, comparative phase 2 study in patients with metastatic clear cell renal cell carcinoma. The goal is to determine the sensitivity of 68Ga-NY104 PET/CT in patients with metastatic clear cell renal cell carcinoma and compare it with 18F-FDG PET/CT.
Detailed description
This is a prospective, single-center, single-arm, comparative phase 2 study in patients with metastatic clear cell renal cell carcinoma. Each patient will receive one dose of 68Ga-NY104 and one dose of 18F-FDG by intravenous route. Dedicated whole-body PET/CT imaging will be performed. PET/CT studies will be interpreted by two readers, both of whom will provide independent, blinded interpretations. Imaging interpretations and a composite reference standard will be used to estimate the sensitivity of each modality. The tumor uptake will also be compared for matched lesions.
39 patients will be recruited in Peking Union Medical College Hospital.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-NY104 PET/CT | Experimental | Diagnostic Test: 68Ga-NY104 PET/CTEach patient will receive one dose of 68Ga-NY104 by intravenous route. Dedicated whole-body PET/CT imaging will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 y
- Histopathological diagnosis of clear cell renal cell carcinoma
- Metastatic disease confirmed by histopathology or typical appearance of multifocal metastatic disease
- Expected survival of at least 6 months
- ECOG ≤ 2
Key exclusion criteria (4 listed)
- On VEGF TKI treatment less than 1 week before 68Ga-NY104 PET/CT. TKI is known to affect girentuximab binding in patients with ccRCC and is expected to have the same effect on 68Ga-NY104. If patients were on VEGF TKI treatment, such as sunitinib, sorafenib, cabozantinib, pazopanib, or lenvatinib, a washout of one week before 68Ga-NY104 PET/CT is required.
- Patients on HIF antagonist treatment < 3 months before 68Ga-NY104 PET/CT. CA9, which encodes carbonic anhydrase IX (CAIX), is one of the genes most strongly upregulated by HIF-1. HIF antagonist, such as Belzutifan, might affect the expression of CAIX and thus the binding of 68Ga-NY104 to tumor. Withdraw of at least 3 months is required for HIF antagonist.
- Pregnancy or breastfeeding.
- Severe claustrophobia.
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 |
|---|---|---|
| 68Ga-NY104 PET/CTAlso: 68Ga-NYM005 PET/CTParticipants will be administered a single, intravenous bolus of 68Ga-NY104 The recommended administered activity of 68Ga-NY104 is 1.8-2.2 MBq per kilogram bodyweight, subject to variation that may be required owing to variable elution efficiencies obtained during the lifetime of the 68Ga / 68Ga generator The CT and PET imaging session will begin approximately 45 to 75 minutes after 68Ga-NY104 administration. | Diagnostic test | 68Ga-NY104 PET/CT |
Primary outcome
Positivity of lesions detected by 68Ga-NY104 PET
Time frame: From study completion to 1 month after completion
Any focal accumulation that cannot be explained by physiologic uptake of the 68Ga-NY104 will be interpreted as focal lesion.
Positivity of lesions detected by 18F-FDG PET
Time frame: From study completion to 1 month after completion
Any focal accumulation that cannot be explained by physiologic uptake of 18F-FDG will be interpreted as focal lesion.
2 secondary outcomes
SUVmax of lesions detected by 68Ga-NY104 PET
Time frame: From study completion to 1 month after completion
SUVmax of lesions detected by 18F-FDG PET
Time frame: From study completion to 1 month after completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Individual participant dataSharing planned: Yes. Available upon request
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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. This study is not recruiting at the moment.
Li Huo, MD principal investigator
Peking Uion Medical College 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 68Ga-NY104 PET/CT in people with Metastatic Clear Cell Renal Cell Carcinoma, run by Peking Union Medical College Hospital at 1 site in China.
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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 24 Jul 2023. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Huo, MD (18612672038, huoli@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positivity of lesions detected by 68Ga-NY104 PET (time frame: From study completion to 1 month after completion). 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 24 Jul 2023.