Carbonic Anhydrase IXNCT06519760
68Ga-C1 PET/ CT Imaging in Clear Cell Renal Cell Carcinoma
A study testing 68Ga-C1 in people with Carbonic Anhydrase IX and PET-CT, run by Peking University First Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the diagnostic value of CAIX protein specific probe 68Ga-C1 in PET/CT imaging in clear cell renal cell carcinoma patients. It will also learn about the safety, tolerability and radiation dosimetry of 68Ga-C1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carbonic Anhydrase IX, PET-CT, Clear Cell Renal Cell Carcinoma
- What is being tested?
- 68Ga-C1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2024to 31 Dec 2026
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed written informed consent；
- Age ≥18；
- Patients with confirmed or suspected clear cell renal cell carcinoma;
- Expected survival ≥6 months.
Who cannot join
- Renal mass is known to be a metastasis of another primary tumor;
- Have other malignancies that require treatment;
- Have received chemotherapy, radiotherapy, or immunotherapy within 4 weeks;
- Renal insufficiency with glomerular filtration rate (GFR) ≤ 60 mL/min/1.73 m²;
- Pregnant and lactating women or female patients plan to become pregnant within 6 months;
- Uncontrolled psychiatric disorders;
- Vulnerable population (e.g., being in detention) or have a serious non-malignant disease (e.g., infectious disease, autoimmune disease, or metabolic disease).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Yanyan Yu, +86 1066119025, bdyyll@126.com
About this study
Official title: Evaluation of Diagnostic Value of 68Ga-C1 PET/ CT Imaging in Clear Cell Renal Cell Carcinoma
The goal of this clinical trial is to evaluate the diagnostic value of CAIX protein specific probe 68Ga-C1 in PET/CT imaging in clear cell renal cell carcinoma patients. It will also learn about the safety, tolerability and radiation dosimetry of 68Ga-C1.
Researchers will compare the diagnostic value of 68Ga-C1 PET/CT and 18F-FDG PET/CT in Chinese patients with indeterminate renal masses or confirmed clear cell renal cell carcinoma.
Read the detailed description
Carbonic anhydrase IX (CAIX) is a transmembrane protein which is highly expressed in approximately 95% of clear cell renal cell carcinomas, and it is closely related to tumor progression, patients prognosis and treatment response. Here, we developed a CAIX specific small molecule probe 68Ga-C1, which has shown a good diagnostic accuracy in PET/CT imaging in our preclinical mouse model of clear cell renal cell carcinoma. This enables high-contrast imaging of clear cell renal carcinoma, providing a new imaging method for the precise diagnosis of clear cell renal carcinoma. In this clinical trail, we will compare the diagnostic value of 68Ga-C1 PET/CT and 18F-FDG PET/CT in Chinese patients with indeterminate renal masses or confirmed clear cell renal cell carcinoma.
- Being tested
- 68Ga-C1
- Keywords
- Carbonic Anhydrase IX, 68Ga-C1, PET-CT, Clear Cell Renal Cell Carcinoma
- 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.
68Ga-C1Drug
Also called CAIX specific PET imaging
68Ga-C1 is injected intravenously with a dose of 0.05-0.10 mCi/kg
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-C1 | Experimental | Subjects with suspected or confirmed clear cell renal cell carcinoma will receive an intravenous injection of 68Ga-C1 followed by PET imaging. The subjects will also receive a whole-body 18F-FDG PET/CT scan within a one-week period. Receives: Drug: 68Ga-C1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic efficacy of 68Ga-C1 PET/CT in the evaluation of clear cell renal cell carcinoma
Compare the standardized Uptake Value (SUV) of lesions on 68Ga-C1 and 18F-FDG PET/CT
Measured: 1 year
The diagnostic efficacy of 68Ga-C1 PET/CT in the evaluation of malignant tumors
Compare the number of lesions detected by 68Ga-C1 and 18F-FDG PET/CT, based on the pathology or clinical follow-up as gold standard.
Measured: 1 year
Secondary outcomes (3)
The dosimetry of 68Ga-C1
Research on the dose distribution of 68Ga-C1 in healthy volunteers and cancer patients by 1-hour dynamic PET/CT acquisition and analyze by the dosimetry software
Measured: 1 year
Quantitative evaluation of 68Ga-C1
Evaluation of quantitative parameters of 68Ga-C1, such as time-activity curve.
Measured: 1 year
Correlation with pathological expression
Analyze CAIX expression at the imaging level in combination with CAIX expression in pathological specimens
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start30 Jul 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbonic Anhydrase IXStudies of the same condition, open and under way.
- More trials run by Peking University First 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GONG Kan, Peking University First Hospital
- Investigators
- Kan Gong, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519760
- Sponsor's protocol ID
- 2024#07-17
- Status last verified
- Nov 2024
- First submitted
- 17 Jul 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Diagnostic Value of 68Ga-C1 PET/ CT Imaging in Clear Cell Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06519760
- Acronym / sponsor ID
- 2024#07-17
- Keywords
- Carbonic Anhydrase IX, 68Ga-C1, PET-CT, Clear Cell Renal Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Jul 2024 (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 evaluate the diagnostic value of CAIX protein specific probe 68Ga-C1 in PET/CT imaging in clear cell renal cell carcinoma patients. It will also learn about the safety, tolerability and radiation dosimetry of 68Ga-C1.
Researchers will compare the diagnostic value of 68Ga-C1 PET/CT and 18F-FDG PET/CT in Chinese patients with indeterminate renal masses or confirmed clear cell renal cell carcinoma.
Detailed description
Carbonic anhydrase IX (CAIX) is a transmembrane protein which is highly expressed in approximately 95% of clear cell renal cell carcinomas, and it is closely related to tumor progression, patients prognosis and treatment response. Here, we developed a CAIX specific small molecule probe 68Ga-C1, which has shown a good diagnostic accuracy in PET/CT imaging in our preclinical mouse model of clear cell renal cell carcinoma. This enables high-contrast imaging of clear cell renal carcinoma, providing a new imaging method for the precise diagnosis of clear cell renal carcinoma. In this clinical trail, we will compare the diagnostic value of 68Ga-C1 PET/CT and 18F-FDG PET/CT in Chinese patients with indeterminate renal masses or confirmed clear cell renal cell carcinoma.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-C1 | Experimental | Drug: 68Ga-C1Subjects with suspected or confirmed clear cell renal cell carcinoma will receive an intravenous injection of 68Ga-C1 followed by PET imaging. The subjects will also receive a whole-body 18F-FDG PET/CT scan within a one-week period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed written informed consent；
- Age ≥18；
- Patients with confirmed or suspected clear cell renal cell carcinoma;
- Expected survival ≥6 months.
Key exclusion criteria (7 listed)
- Renal mass is known to be a metastasis of another primary tumor;
- Have other malignancies that require treatment;
- Have received chemotherapy, radiotherapy, or immunotherapy within 4 weeks;
- Renal insufficiency with glomerular filtration rate (GFR) ≤ 60 mL/min/1.73 m²;
- Pregnant and lactating women or female patients plan to become pregnant within 6 months;
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-C1Also: CAIX specific PET imaging68Ga-C1 is injected intravenously with a dose of 0.05-0.10 mCi/kg | Drug | 68Ga-C1 |
Primary outcome
The diagnostic efficacy of 68Ga-C1 PET/CT in the evaluation of clear cell renal cell carcinoma
Time frame: 1 year
Compare the standardized Uptake Value (SUV) of lesions on 68Ga-C1 and 18F-FDG PET/CT
The diagnostic efficacy of 68Ga-C1 PET/CT in the evaluation of malignant tumors
Time frame: 1 year
Compare the number of lesions detected by 68Ga-C1 and 18F-FDG PET/CT, based on the pathology or clinical follow-up as gold standard.
3 secondary outcomes
The dosimetry of 68Ga-C1
Time frame: 1 year
Quantitative evaluation of 68Ga-C1
Time frame: 1 year
Correlation with pathological expression
Time frame: 1 year
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 7 Nov 2024.
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An Investigational Scan (89Zr-DFO-GmAb PET/CT) Compared to Contrast-Enhanced CT for the Detection of Recurrent Clear Cell Renal Cell Cancer After Surgery Comparing Carbonic Anhydrase IX (CAIX) PET CT to Conventional PET CT for Post-Op Staging in Kidney Cancer
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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.
Kan Gong principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga-C1 in people with Carbonic Anhydrase IX and PET-CT, run by Peking University First 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 4 inclusion and 7 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 7 Nov 2024. 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.
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 Kan Gong ((86)-010-83572075, kan.gong@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diagnostic efficacy of 68Ga-C1 PET/CT in the evaluation of clear cell renal cell carcinoma (time frame: 1 year). 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 7 Nov 2024.