Clear Cell Renal Cell Cancer (ccRCC)NCT07557225
18F-T2 PET/CT Imaging for CAIX Positive Solid Tumors
A study testing 18F-T2 PET/CT in people with Clear Cell Renal Cell Cancer (ccRCC) and Urothelial Carcinoma (UC), 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 18F-T2 in PET/CT imaging in participants with solid tumors. It will also assess the safety, tolerability and radiation dosimetry of 18F-T2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Clear Cell Renal Cell Cancer (ccRCC), Urothelial Carcinoma (UC), Colorectal Cancer
- What is being tested?
- 18F-T2 PET/CT
- 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
- 27 Apr 2026to Mar 2029
- 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
- All participants must meet the following criteria:
- Written and voluntarily given Informed Consent.
- Male or female ≥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.
- Participants with histologically confirmed or suspected tumors of the following types, but not limited to:
- Clear Cell Renal Cell Cancer; Urothelial Carcinoma; Colorectal Cancer; Cervical Cancer; Ovarian Cancer; Head and Neck Cancer; Hepatocellular Carcinoma; Cholangiocarcinoma; Non Small Cell Lung Cancer; Small Cell Lung Cancer; Breast Cancer; Pancreatic Cancer; Endometrial Cancer; Von Hippel Lindau Disease.
Who cannot join
- Participants will be excluded from participation in the study if one or more of the following criteria are met:
- Have any serious non-malignant disease (e.g., psychiatric, infectious, autoimmune or metabolic) that may interfere with the objectives of the study or with the safety or compliance of the participant, as judged by the Investigator.
- Have a mental impairment that may compromise the ability to give Informed Consent and comply with the requirements of the study.
- Be a female who is pregnant or breastfeeding.
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
Peking University First Hospital, +86 010-83576401, bdyyll@126.com
About this study
Official title: Evaluation of Diagnostic Value of 18F-T2 PET/ CT Imaging for Tumors Likely to Express High Levels of CAIX
The goal of this clinical trial is to evaluate the diagnostic value of CAIX protein specific probe 18F-T2 in PET/CT imaging in participants with solid tumors. It will also assess the safety, tolerability and radiation dosimetry of 18F-T2.
- Conditions
- Clear Cell Renal Cell Cancer (ccRCC), Urothelial Carcinoma (UC), Colorectal Cancer, Cervical Cancer, Ovarian Cancer, Head and Neck Cancer
- Being tested
- 18F-T2 PET/CT
- Medical subject headings
- Carcinoma, Renal Cell, Carcinoma, Transitional Cell, Colorectal Neoplasms, Uterine Cervical Neoplasms, Ovarian Neoplasms, Head and Neck Neoplasms, Carcinoma, Hepatocellular, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-T2 PET/CTDiagnostic test
18F-T2 is injected intravenously with a dose of 0.05-0.10 mCi/kg. The CT and PET imaging session will begin approximately 60 minutes after 18F-T2 administration.
| Study group | Role | What they receive |
|---|---|---|
| 18F-T2 PET/CT | Experimental | Participants with tumors likely to express high levels of CAIX will receive an intravenous injection of 18F-T2 followed by PET/CT imaging. The participants will also receive a whole-body 18F-FDG PET/CT scan within a one-week period. Receives: Diagnostic Test: 18F-T2 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Diagnostic Sensitivity and Specificity of 18F-T2 PET/CT in the Evaluation of CAIX Positive Solid Tumors
The diagnostic performance of 18F-T2 PET/CT and 18F-FDG PET/CT for staging will be evaluated and compared, using histopathological findings as the gold standard or, if not available, follow-up clinical and conventional imaging examinations (ultrasound, CT, or MRI) for at least 3 months as the reference standard.
Measured: From study completion to 1 month after completion
Incidence of Adverse Events [Safety and Tolerability]
Safety of administration of 18F-T2, according to Common Terminology Criteria for Adverse Events (CTCAE v6.0).
Measured: 24 hours after the injection of 18F-T2
Secondary outcomes (4)
Maximum Standardized Uptake Value [SUVmax] of Primary and Metastatic Lesions on 18F-T2 PET/CT vs. 18F-FDG PET/CT
Comparison of maximum standardized uptake value (SUVmax) of primary and metastatic lesions between 18F-T2 PET/CT and 18F-FDG PET/CT.
Measured: From study completion to 1 month after completion
Mean Standardized Uptake Value [SUVmean] of Primary and Metastatic Lesions on 18F-T2 PET/CT vs. 18F-FDG PET/CT
Comparison of mean standardized uptake value (SUVmean) of primary and metastatic lesions between 18F-T2 PET/CT and 18F-FDG PET/CT.
Measured: From study completion to 1 month after completion
Correlation between T2 Uptake and CAIX Pathological Expression
Evaluation of the correlation between uptake parameters derived from 18F-T2 PET/CT and CAIX expression level measured by immunohistochemistry (IHC) in tumor tissue samples.
Measured: From study completion to 1 month after completion
Dosimetry of 18F-T2
Research on the dose distribution of 18F-T2 in healthy volunteers and cancer patients by 1-hour dynamic PET/CT acquisition and analyze by the dosimetry software.
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 posted29 Apr 2026
- Study start27 Apr 2026
- Primary completionSep 2028 (estimated)
- Study completionMar 2029 (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 Cancer (ccRCC)Studies 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 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, Meng LIU, Peking University First Hospital
- Investigators
- Meng Liu, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557225
- Sponsor's protocol ID
- FCAIX002
- Status last verified
- May 2026
- First submitted
- 22 Apr 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Diagnostic Value of 18F-T2 PET/ CT Imaging for Tumors Likely to Express High Levels of CAIX
- ClinicalTrials.gov ID
- NCT07557225
- Acronym / sponsor ID
- FCAIX002
- Conditions
- Clear Cell Renal Cell Cancer (ccRCC), Urothelial Carcinoma (UC), Colorectal Cancer, Cervical Cancer, Ovarian Cancer, Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 29 Apr 2026 (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 18F-T2 in PET/CT imaging in participants with solid tumors. It will also assess the safety, tolerability and radiation dosimetry of 18F-T2.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-T2 PET/CT | Experimental | Diagnostic Test: 18F-T2 PET/CTParticipants with tumors likely to express high levels of CAIX will receive an intravenous injection of 18F-T2 followed by PET/CT imaging. The participants 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 (6 listed)
- Written and voluntarily given Informed Consent.
- Male or female ≥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.
- Participants with histologically confirmed or suspected tumors of the following types, but not limited to:
- Clear Cell Renal Cell Cancer; Urothelial Carcinoma; Colorectal Cancer; Cervical Cancer; Ovarian Cancer; Head and Neck Cancer; Hepatocellular Carcinoma; Cholangiocarcinoma; Non Small Cell Lung Cancer; Small Cell Lung Cancer; Breast Cancer; Pancreatic Cancer; Endometrial Cancer; Von Hippel Lindau Disease.
Key exclusion criteria (4 listed)
- Participants will be excluded from participation in the study if one or more of the following criteria are met:
- Have any serious non-malignant disease (e.g., psychiatric, infectious, autoimmune or metabolic) that may interfere with the objectives of the study or with the safety or compliance of the participant, as judged by the Investigator.
- Have a mental impairment that may compromise the ability to give Informed Consent and comply with the requirements of the study.
- Be a female who is pregnant or breastfeeding.
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-T2 PET/CT18F-T2 is injected intravenously with a dose of 0.05-0.10 mCi/kg. The CT and PET imaging session will begin approximately 60 minutes after 18F-T2 administration. | Diagnostic test | 18F-T2 PET/CT |
Primary outcome
The Diagnostic Sensitivity and Specificity of 18F-T2 PET/CT in the Evaluation of CAIX Positive Solid Tumors
Time frame: From study completion to 1 month after completion
The diagnostic performance of 18F-T2 PET/CT and 18F-FDG PET/CT for staging will be evaluated and compared, using histopathological findings as the gold standard or, if not available, follow-up clinical and conventional imaging examinations (ultrasound, CT, or MRI) for at least 3 months as the reference standard.
Incidence of Adverse Events [Safety and Tolerability]
Time frame: 24 hours after the injection of 18F-T2
Safety of administration of 18F-T2, according to Common Terminology Criteria for Adverse Events (CTCAE v6.0).
4 secondary outcomes
Maximum Standardized Uptake Value [SUVmax] of Primary and Metastatic Lesions on 18F-T2 PET/CT vs. 18F-FDG PET/CT
Time frame: From study completion to 1 month after completion
Mean Standardized Uptake Value [SUVmean] of Primary and Metastatic Lesions on 18F-T2 PET/CT vs. 18F-FDG PET/CT
Time frame: From study completion to 1 month after completion
Correlation between T2 Uptake and CAIX Pathological Expression
Time frame: From study completion to 1 month after completion
Dosimetry of 18F-T2
Time frame: From study completion to 1 month after completion
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 14 May 2026.
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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.
Meng Liu 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 18F-T2 PET/CT in people with Clear Cell Renal Cell Cancer (ccRCC) and Urothelial Carcinoma (UC), 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 6 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: looking for participants now, as of the sponsor's last update on 14 May 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 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 Keting Tong (+86 010-83575252, 1910301229@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Diagnostic Sensitivity and Specificity of 18F-T2 PET/CT in the Evaluation of CAIX Positive Solid Tumors (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 14 May 2026.