Kidney CancersEarly Phase 1NCT07590310
Clinical Application of CAIX-Targeted PET Imaging in Tumors
A Early Phase 1 study testing Each patient will undergo 68Ga/18F-CAIX-LT-BCH PET/CT imaging, with an administered radioactive dose of approximately 0.05-0.1 mCi/kg. in people with Kidney Cancers, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
According to the 2020 global cancer statistics, renal carcinoma ranks as the fourteenth most common malignant tumor worldwide. In 2020, there were 431,288 new cases and 179,368 deaths from renal cancer, and both the incidence and mortality rates are projected to continue rising by 2025. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Cancers
- What is being tested?
- Each patient will undergo 68Ga/18F-CAIX-LT-BCH PET/CT imaging, with an administered radioactive dose of approximately 0.05-0.1 mCi/kg.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 31 Dec 2026
- Phase
- Early Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Hematological, hepatic, and renal functions meeting the following criteria: Complete Blood Count: WBC ≥4.0×10⁹/L or Neutrophils ≥1.5×10⁹/L, PLT ≥100×10⁹/L, Hb ≥90 g/L; Coagulation: PT or APTT ≤1.5 × ULN (Upper Limit of Normal); Hepatic Function: T-Bil ≤1.5 × ULN; ALT/AST ≤2.5 × ULN (or ≤5 × ULN for subjects with liver metastases); ALP ≤2.5 × ULN (or ≤4.5 × ULN for subjects with bone or liver metastases); Renal Function: BUN ≤1.5 × ULN, SCr ≤1.5 × ULN.
- Normal cardiac function;
- Expected survival ≥12 weeks;
- Good compliance with follow-up;
- At least one measurable target lesion according to RECIST 1.1 criteria;
- Women of childbearing potential (aged 18-49) must have a negative pregnancy test within 7 days prior to the examination. Male and female patients of childbearing potential must agree to use effective contraception to prevent pregnancy during the study and for 3 months after the examination;
- Patients for whom the clinician recommends a PET/CT examination for tumor diagnosis and staging;
- Patients are fully capable of understanding the study, voluntarily agree to participate, and provide written informed consent.
Who cannot join
- Severe abnormalities in hepatic, renal, or hematological function;
- Patients planning for pregnancy;
- Pregnant or lactating women;
- Inability to lie flat for 30 minutes;
- Refusal to participate in this clinical study;
- Presence of claustrophobia or other psychiatric disorders;
- Any other condition deemed unsuitable for participation by the investigator.
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 Cancer Hospital
Beijing, Haidian, 10000
About this study
According to the 2020 global cancer statistics, renal carcinoma ranks as the fourteenth most common malignant tumor worldwide. In 2020, there were 431,288 new cases and 179,368 deaths from renal cancer, and both the incidence and mortality rates are projected to continue rising by 2025. Early non-invasive diagnosis of clear cell renal cell carcinoma (ccRCC) is crucial for improving prognosis. Nuclear medicine molecular imaging offers the advantages of real-time, dynamic, and non-invasive detection of lesions throughout the body. However, there is currently a lack of highly efficient and targeted molecular probes for early and accurate diagnosis of this tumor in clinical practice.
The high expression of CAIX plays a central role in the pathogenesis of renal cancer by altering cellular metabolism, inducing angiogenesis, promoting epithelial-mesenchymal transition (EMT), invasion, and metastatic spread. CAIX is highly expressed in 95% of ccRCC cases. In fact, CAIX expression levels have been reported as an independent predictor of survival in advanced ccRCC. Moreover, CAIX expression in normal tissues is limited, primarily restricted to the stomach, the basolateral aspects of proliferating small intestinal crypt epithelial cells, and the gallbladder. Therefore, the differential expression of CAIX between ccRCC tumors and normal tissues highlights its potential as a robust target for nuclear medicine molecular probe research and development in ccRCC.
This study utilized high-throughput screening to identify small molecules with high affinity for CAIX. These molecules were subsequently cyclized and modified to enhance their in vivo stability. A bifunctional chelator, H3RESCA, was introduced at the C-terminus to construct the small-molecule compound RESCA-CAIX-LT. PET probes were prepared by radiolabeling with 68Ga or 18F, and their diagnostic efficacy for renal cancer was investigated. Small-animal PET imaging initially demonstrated that the probe exhibits high affinity and excellent imaging performance. The modifications also altered the in vivo metabolic profile of the original design, reducing non-specific uptake in organs such as the stomach, small intestine, and gallbladder. Furthermore, toxicological experiments confirmed the probe's high safety profile and in vivo stability.
- Conditions
- Kidney Cancers
- Being tested
- Each patient will undergo 68Ga/18F-CAIX-LT-BCH PET/CT imaging, with an administered radioactive dose of approximately 0.05-0.1 mCi/kg.
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Each patient will undergo 68Ga/18F-CAIX-LT-BCH PET/CT imaging, with an administered radioactive dose of approximately 0.05-0.1 mCi/kg.Drug
68Ga/18F-CAIX-LT-BCH (0.05-0.1 mCi/kg) is intravenously administered, followed immediately by whole-body dynamic imaging using the United Imaging uEXPLORER total-body PET/CT system. If indeterminate lesions are observed on routine imaging, delayed imaging may be performed for further evaluation. The patient is positioned supine and instructed to breathe quietly. The acquired data are reconstructed using the Ordered Subset Expectation Maximization (OSEM) algorithm to generate dynamic PET image frames.
Static PET/CT or PET/MRI Protocol:
Following intravenous administration of the quality-controlled 68Ga/18F-CAIX-LT-BCH (0.05-0.1 mCi/kg), the patient rests for 50-60 minutes before undergoing whole-body or regional static scanning. The patient is positioned supine and maintains quiet breathing. Image data are reconstructed using the OSEM algorithm to produce dynamic PET image frames.
| Study group | Role | What they receive |
|---|---|---|
| Renal cancer patients | Experimental | This is an exploratory study. Initially, we plan to enroll renal cancer patients or suspected patients scheduled for pathological biopsy or surgical tumor resection within the next 2 months. Following the collection of preliminary sample data, a further analysis will be conducted to calculate the required sample size. Receives: Drug: Each patient will undergo 68Ga/18F-CAIX-LT-BCH PET/CT imaging, with an administered radioactive dose of approximately 0.05-0.1 mCi/kg. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized Uptake Value (SUV) of target or suspected tumor lesions in malignant tumor subjects for 68Ga/18F-CAIX-LT-BCH across imaging time points
Measured: Immediately after completion of imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start1 Mar 2025
- Primary completion31 Dec 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 Kidney CancersStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590310
- Sponsor's protocol ID
- 2025YJZ37
- Status last verified
- May 2026
- First submitted
- 11 Dec 2025
- Last updated
- 15 May 2026
- 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 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of CAIX-Targeted PET Imaging in Tumors
- ClinicalTrials.gov ID
- NCT07590310
- Acronym / sponsor ID
- 2025YJZ37
- Conditions
- Kidney Cancers
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 May 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.
According to the 2020 global cancer statistics, renal carcinoma ranks as the fourteenth most common malignant tumor worldwide. In 2020, there were 431,288 new cases and 179,368 deaths from renal cancer, and both the incidence and mortality rates are projected to continue rising by 2025. Early non-invasive diagnosis of clear cell renal cell carcinoma (ccRCC) is crucial for improving prognosis. Nuclear medicine molecular imaging offers the advantages of real-time, dynamic, and non-invasive detection of lesions throughout the body. However, there is currently a lack of highly efficient and targeted molecular probes for early and accurate diagnosis of this tumor in clinical practice.
The high expression of CAIX plays a central role in the pathogenesis of renal cancer by altering cellular metabolism, inducing angiogenesis, promoting epithelial-mesenchymal transition (EMT), invasion, and metastatic spread. CAIX is highly expressed in 95% of ccRCC cases. In fact, CAIX expression levels have been reported as an independent predictor of survival in advanced ccRCC. Moreover, CAIX expression in normal tissues is limited, primarily restricted to the stomach, the basolateral aspects of proliferating small intestinal crypt epithelial cells, and the gallbladder. Therefore, the differential expression of CAIX between ccRCC tumors and normal tissues highlights its potential as a robust target for nuclear medicine molecular probe research and development in ccRCC.
This study utilized high-throughput screening to identify small molecules with high affinity for CAIX. These molecules were subsequently cyclized and modified to enhance their in vivo stability. A bifunctional chelator, H3RESCA, was introduced at the C-terminus to construct the small-molecule compound RESCA-CAIX-LT. PET probes were prepared by radiolabeling with 68Ga or 18F, and their diagnostic efficacy for renal cancer was investigated. Small-animal PET imaging initially demonstrated that the probe exhibits high affinity and excellent imaging performance. The modifications also altered the in vivo metabolic profile of the original design, reducing non-specific uptake in organs such as the stomach, small intestine, and gallbladder. Furthermore, toxicological experiments confirmed the probe's high safety profile and in vivo stability.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal cancer patients | Experimental | Drug: Each patient will undergo 68Ga/18F-CAIX-LT-BCH PET/CT imaging, with an administered radioactive dose of approximately 0.05-0.1 mCi/kg.This is an exploratory study. Initially, we plan to enroll renal cancer patients or suspected patients scheduled for pathological biopsy or surgical tumor resection within the next 2 months. Following the collection of preliminary sample data, a further analysis will be conducted to calculate the required sample size. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- -Hematological, hepatic, and renal functions meeting the following criteria: Complete Blood Count: WBC ≥4.0×10⁹/L or Neutrophils ≥1.5×10⁹/L, PLT ≥100×10⁹/L, Hb ≥90 g/L; Coagulation: PT or APTT ≤1.5 × ULN (Upper Limit of Normal); Hepatic Function: T-Bil ≤1.5 × ULN; ALT/AST ≤2.5 × ULN (or ≤5 × ULN for subjects with liver metastases); ALP ≤2.5 × ULN (or ≤4.5 × ULN for subjects with bone or liver metastases); Renal Function: BUN ≤1.5 × ULN, SCr ≤1.5 × ULN.
- Normal cardiac function;
- Expected survival ≥12 weeks;
- Good compliance with follow-up;
- At least one measurable target lesion according to RECIST 1.1 criteria;
Key exclusion criteria (7 listed)
- Severe abnormalities in hepatic, renal, or hematological function;
- Patients planning for pregnancy;
- Pregnant or lactating women;
- Inability to lie flat for 30 minutes;
- Refusal to participate in this clinical study;
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 |
|---|---|---|
| Each patient will undergo 68Ga/18F-CAIX-LT-BCH PET/CT imaging, with an administered radioactive dose of approximately 0.05-0.1 mCi/kg.68Ga/18F-CAIX-LT-BCH (0.05-0.1 mCi/kg) is intravenously administered, followed immediately by whole-body dynamic imaging using the United Imaging uEXPLORER total-body PET/CT system. If indeterminate lesions are observed on routine imaging, delayed imaging may be performed for further evaluation. The patient is positioned supine and instructed to breathe quietly. The acquired data are reconstructed using the Ordered Subset Expectation Maximization (OSEM) algorithm to generate dynamic PET image frames. Static PET/CT or PET/MRI Protocol: Following intravenous administration of the quality-controlled 68Ga/18F-CAIX-LT-BCH (0.05-0.1 mCi/kg), the patient rests for 50-60 minutes before undergoing whole-body or regional static scanning. The patient is positioned supine and maintains quiet breathing. Image data are reconstructed using the OSEM algorithm to produce dynamic PET image frames. | Drug | Renal cancer patients |
Primary outcome
Standardized Uptake Value (SUV) of target or suspected tumor lesions in malignant tumor subjects for 68Ga/18F-CAIX-LT-BCH across imaging time points
Time frame: Immediately after completion of imaging
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 15 May 2026.
- 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?
A Early Phase 1 study testing Each patient will undergo 68Ga/18F-CAIX-LT-BCH PET/CT imaging, with an administered radioactive dose of approximately 0.05-0.1 mCi/kg. in people with Kidney Cancers, run by Peking University Cancer Hospital & Institute 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 8 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 15 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Lei Xia (+86 18811177191, xialei9012288@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized Uptake Value (SUV) of target or suspected tumor lesions in malignant tumor subjects for 68Ga/18F-CAIX-LT-BCH across imaging time points (time frame: Immediately after completion of imaging). 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 15 May 2026.