CAIX-targeted PET imaging to help diagnose kidney cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early Phase 1 trial investigates whether 68Ga/18F-CAIX-LT-BCH PET/CT can safely image CAIX-expressing kidney tumors. Eligible participants have confirmed kidney cancer with at least one measurable lesion and adequate organ function. Participants will receive a single PET/CT scan after administration of the tracer to assess imaging quality, safety, and preliminary tumor targeting. The study emphasizes non-invasive, real-time visualization of tumors to support diagnosis and treatment planning. Overall, results will inform feasibility and potential utility of CAIX-directed molecular imaging in ccRCC.

Why it matters

Who can join: the full rules

Inclusion Criteria:

-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.

Exclusion Criteria:

* 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.

Where it's running

• Peking University Cancer Hospital
  Beijing, Haidian, China Recruiting

Study contacts

• Study coordinator: Lei Xia
• Email: xialei9012288@126.com
• Phone: +86 18811177191

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Can Gleolan help highlight kidney tumors during partial nephrectomy?

  This study tests whether giving Gleolan before kidney surgery helps fluorescence identify cancer tissue in adults with suspected kidney cancer undergoing partial nephrectomy.

  Recruiting Phase 2 Henry Ford Health System · Detroit, Michigan · NCT07828704

• Personalized 3D Tumoroids from Your Tumor to Test Treatments

  Researchers are using patient tumor tissue and blood to grow personalized 3D, vascularized tumoroids with autologous immune cells to help tailor treatments for kidney, bladder, and prostate cancers.

  Recruiting University Hospital, Strasbourg, France · Strasbourg · NCT07820566

• NEO-811 for advanced or metastatic clear cell kidney cancer

  This study will try the experimental oral drug NEO-811 in people with locally advanced or metastatic clear cell kidney cancer who have progressed on or refused standard treatments.

  Recruiting at 16 sites Phase 1 Neomorph, Inc · Duarte, California and 15 other locations · NCT07300241

• Abdominal CT offered alongside lung screening for people who have smoked

  We will test whether mentioning a possible extra abdominal CT in the lung screening invitation changes whether people aged 55–70 who have ever smoked attend their lung screening appointment.

  Recruiting University of Cambridge · Hull · NCT07171190

• Comprehensive pre-surgery conditioning, with or without planned preoperative cancer therapy, before major abdominal or pelvic cancer operations.

  This trial will test whether a comprehensive prehabilitation program, given alone or with planned neoadjuvant therapy, helps pre-frail or frail adults with pancreatic, ovarian, kidney, or bladder cancer better tolerate major cancer surgery.

  Recruiting Phase 2 The Methodist Hospital Research Institute · Houston, Texas · NCT07050771

• Targeted alpha therapy [212Pb]VMT-Alpha-NET for SSTR-positive metastatic or inoperable GI neuroendocrine, pheochromocytoma/paraganglioma, small cell lung, kidney, and head & neck cancers

  This trial will try an experimental targeted alpha-particle drug called [212Pb]VMT-Alpha-NET in adults whose metastatic or inoperable tumors show somatostatin receptor (SSTR) expression.

  Recruiting Phase 1 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT06479811

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.