TumorNCT06956144
Exploring the Clinical Application Value of CAIX-Targeted PET Imaging in Renal Cancer Patients
An observational study of Tumor and Carbonic Anhydrase IX, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
To evaluate the efficacy of targeted CAIX-specific probe PET imaging in the diagnosis and staging of kidney cancer, as well as to assess its role in prognosis prediction and treatment evaluation for kidney cancer. Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Tumor, Carbonic Anhydrase IX
- Type of treatment
- Injection or infusion
- How many people
- 113 participants
- Where
- 1 siteChina
- Study dates
- 9 May 2025to 30 Sep 2026
- Phase
- Observational
- 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 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Adult patients (age between 18 and 75 years), regardless of gender. 2. Patients with clinically suspected or confirmed primary kidney cancer (supporting evidence includes imaging data and histopathological examination; specific case types include clear cell carcinoma, papillary renal cell carcinoma, and chromophobe renal cell carcinoma) who agree to undergo histopathological examination (if not already performed prior to imaging). 3. Patients must have undergone enhanced CT, with the enhanced CT examination conducted within 2 weeks prior to enrollment. 4. ECOG performance status score of 0-3. 5. Laboratory parameters must meet the following criteria: 1. ALT and AST must not exceed 3 times the upper limit of normal; BUN and creatinine must not exceed 1.5 times the upper limit of normal. 2. Hematological parameters: 2 x 10^9/L ≤ WBC ≤ 2 x 10^10/L, PLT ≥ 80 x 10^9/L, Hb ≥ 80 g/L.
Who may be able to join
- Voluntary participation with the patient or their legal representative able to sign the informed consent form.
- Adult patients (age between 18 and 75 years), regardless of gender.
- Patients with clinically suspected or confirmed primary kidney cancer (supporting evidence includes imaging data and histopathological examination; specific case types include clear cell carcinoma, papillary renal cell carcinoma, and chromophobe renal cell carcinoma) who agree to undergo histopathological examination (if not already performed prior to imaging).
- Patients must have undergone enhanced CT, with the enhanced CT examination conducted within 2 weeks prior to enrollment.
- ECOG performance status score of 0-3.
- Laboratory parameters must meet the following criteria:
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- ALT and AST must not exceed 3 times the upper limit of normal; BUN and creatinine must not exceed 1.5 times the upper limit of normal.
- Hematological parameters: 2 x 10^9/L ≤ WBC ≤ 2 x 10^10/L, PLT ≥ 80 x 10^9/L, Hb ≥ 80 g/L.
- Willing and able to comply with follow-up visits, treatment plans, and related laboratory examinations.
Who cannot join
- Pregnant or breastfeeding patients (all women of childbearing age must undergo pregnancy testing during the screening phase, such as a urine pregnancy test or blood HCG test, to confirm their pregnancy status).
- Patients or their legal representatives who are unable or unwilling to sign the informed consent form.
- Acute systemic diseases and electrolyte imbalances.
- Patients unable to complete the PET/CT examination (including those unable to lie flat, those with claustrophobia, radiophobia, etc.).
- Researchers believe that the patient has poor compliance or has other factors making them unsuitable for participation in this study.
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
The First Affiliated Hospital of Xiamen University, Xiamen, Fujian 361000
Xiamen
Haojun Chen, 86-592-2137077, leochen0821@foxmail.com
About this study
To evaluate the efficacy of targeted CAIX-specific probe PET imaging in the diagnosis and staging of kidney cancer, as well as to assess its role in prognosis prediction and treatment evaluation for kidney cancer.
Read the detailed description
Images will be analyzed by at least two physicians with extensive experience in nuclear medicine and radiological diagnostics. Regions of interest (ROIs) will be delineated for the lesion tissues to measure volume and SUV values. The interpreted PET/CT imaging results will be compared to the corresponding histopathological results of the lesions (obtained through biopsy or surgery) and will be used as the reference standard. We will employ McNemar's test to compare the sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of targeted CAIX PET/CT imaging and enhanced CT in primary tumors, metastatic lymph nodes, and distant metastatic lesions.
- Conditions
- Tumor, Carbonic Anhydrase IX
- Keywords
- PET, CAIX, Renal Cancer, diagnosis
- Medical subject headings
- Neoplasms, Kidney Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: CAIX-PET/CT | Each participant receives a single intravenous injection of CAIX-PET/CT, and undergo PET/CT imaging within the specified time. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the clinical diagnostic efficacy
To evaluate the clinical diagnostic efficacy (sensitivity, specificity, accuracy) of targeted CAIX PET/CT imaging in the diagnosis and staging of kidney cancer
Measured: 3 Months
Secondary outcomes (1)
Assess the clinical added value
To assess the clinical added value of targeted CAIX PET/CT molecular imaging technology in the diagnosis and staging of kidney cancer by comparing it with enhanced CT.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start9 May 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 113 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956144
- Sponsor's protocol ID
- XMFHIIT-2025SL048
- Status last verified
- Apr 2025
- First submitted
- 25 Apr 2025
- Last updated
- 29 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Clinical Application Value of CAIX-Targeted PET Imaging in Renal Cancer Patients
- ClinicalTrials.gov ID
- NCT06956144
- Acronym / sponsor ID
- XMFHIIT-2025SL048
- Conditions
- Tumor, Carbonic Anhydrase IX
- Keywords
- PET, CAIX, Renal Cancer, diagnosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 113 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 9 May 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 2 May 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.
To evaluate the efficacy of targeted CAIX-specific probe PET imaging in the diagnosis and staging of kidney cancer, as well as to assess its role in prognosis prediction and treatment evaluation for kidney cancer.
Detailed description
Images will be analyzed by at least two physicians with extensive experience in nuclear medicine and radiological diagnostics. Regions of interest (ROIs) will be delineated for the lesion tissues to measure volume and SUV values. The interpreted PET/CT imaging results will be compared to the corresponding histopathological results of the lesions (obtained through biopsy or surgery) and will be used as the reference standard. We will employ McNemar's test to compare the sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of targeted CAIX PET/CT imaging and enhanced CT in primary tumors, metastatic lymph nodes, and distant metastatic lesions.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: CAIX-PET/CT | – | –Each participant receives a single intravenous injection of CAIX-PET/CT, and undergo PET/CT imaging within the specified time. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Adult patients (age between 18 and 75 years), regardless of gender. 2. Patients with clinically suspected or confirmed primary kidney cancer (supporting evidence includes imaging data and histopathological examination; specific case types include clear cell carcinoma, papillary renal cell carcinoma, and chromophobe renal cell carcinoma) who agree to undergo histopathological examination (if not already performed prior to imaging). 3. Patients must have undergone enhanced CT, with the enhanced CT examination conducted within 2 weeks prior to enrollment. 4. ECOG performance status score of 0-3. 5. Laboratory parameters must meet the following criteria: 1. ALT and AST must not exceed 3 times the upper limit of normal; BUN and creatinine must not exceed 1.5 times the upper limit of normal. 2. Hematological parameters: 2 x 10^9/L ≤ WBC ≤ 2 x 10^10/L, PLT ≥ 80 x 10^9/L, Hb ≥ 80 g/L.
Key inclusion criteria (9 listed)
- Voluntary participation with the patient or their legal representative able to sign the informed consent form.
- Adult patients (age between 18 and 75 years), regardless of gender.
- Patients with clinically suspected or confirmed primary kidney cancer (supporting evidence includes imaging data and histopathological examination; specific case types include clear cell carcinoma, papillary renal cell carcinoma, and chromophobe renal cell carcinoma) who agree to undergo histopathological examination (if not already performed prior to imaging).
- Patients must have undergone enhanced CT, with the enhanced CT examination conducted within 2 weeks prior to enrollment.
- ECOG performance status score of 0-3.
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding patients (all women of childbearing age must undergo pregnancy testing during the screening phase, such as a urine pregnancy test or blood HCG test, to confirm their pregnancy status).
- Patients or their legal representatives who are unable or unwilling to sign the informed consent form.
- Acute systemic diseases and electrolyte imbalances.
- Patients unable to complete the PET/CT examination (including those unable to lie flat, those with claustrophobia, radiophobia, etc.).
- Researchers believe that the patient has poor compliance or has other factors making them unsuitable for participation in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the clinical diagnostic efficacy
Time frame: 3 Months
To evaluate the clinical diagnostic efficacy (sensitivity, specificity, accuracy) of targeted CAIX PET/CT imaging in the diagnosis and staging of kidney cancer
1 secondary outcome
Assess the clinical added value
Time frame: 6 Months
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 29 May 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tumor and Carbonic Anhydrase IX, run by The First Affiliated Hospital of Xiamen University 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 9 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 29 May 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 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 Haojun Chen (86-592-2137077, leochen0821@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the clinical diagnostic efficacy (time frame: 3 Months). 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 29 May 2025.