Actively Recruiting

Early Phase 1
Age: 18Years - 75Years
All Genders
ID07590310

Clinical Application of CAIX-Targeted PET Imaging in Tumors for Kidney Cancer Diagnosis

Led by Peking University Cancer Hospital & Institute · Updated on 2026-05-15

3

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Renal carcinoma is a common malignant tumor worldwide, with increasing cases and deaths projected by 2025. Early non-invasive diagnosis of clear cell renal cell carcinoma (ccRCC) is important to improve outcomes. This trial investigates the use of CAIX-targeted PET imaging probes, which bind to a protein highly expressed in most ccRCC tumors, to help with early and accurate detection of renal cancer. The study uses a small molecule called RESCA-CAIX-LT that is modified to be stable in the body and labeled with radioactive substances 68Ga or 18F. These probes are administered intravenously at a dose of about 0.05-0.1 mCi/kg. After injection, whole-body dynamic and static PET/CT scans are performed to visualize tumors. The imaging is done using advanced PET/CT equipment and may include delayed scans for unclear lesions. Participants will be patients with renal cancer or suspected cases who are scheduled for biopsy or surgery soon. Researchers will measure the uptake of the imaging probe in tumor lesions to assess diagnostic performance. The trial includes safety monitoring, imaging evaluations, and follow-up to determine how well the probe detects tumors. Participants will be involved in scanning procedures and assessments over the study period.

CONDITIONS

Brief Title

Clinical Application of CAIX-Targeted PET Imaging in Tumors

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 75 years
  • Adequate blood counts: WBC  4.0 x10^9/L or neutrophils  1.5 x10^9/L, platelets  100 x10^9/L, hemoglobin  90 g/L
  • Coagulation parameters: PT or APTT  1.5 times upper limit of normal
  • Liver function: total bilirubin  1.5 times upper limit of normal; ALT/AST  2.5 times upper limit (or  5 times if liver metastases present); ALP  2.5 times upper limit (or  4.5 times if bone or liver metastases present)
  • Kidney function: BUN and serum creatinine  1.5 times upper limit of normal
  • Normal heart function
  • Expected survival of at least 12 weeks
  • At least one measurable tumor lesion per RECIST 1.1 criteria
  • Women of childbearing age (18-49) must have a negative pregnancy test within 7 days before imaging
  • Male and female patients of childbearing potential must agree to use effective contraception during the study and for 3 months after
  • Clinician recommends PET/CT for tumor diagnosis or staging
  • Ability to understand and consent to the study voluntarily
Not Eligible

You will not qualify if you...

  • Severe blood, liver, or kidney function abnormalities
  • Planning pregnancy
  • Pregnant or breastfeeding women
  • Unable to lie flat for 30 minutes
  • Refusal to participate in the study
  • Claustrophobia or psychiatric disorders
  • Any condition deemed unsuitable by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for eligibility assessment including blood tests and pregnancy test if applicable

Diagnostic Evaluation

Duration - 1 day

Participants undergo 68Ga/18F-CAIX-LT-BCH PET/CT imaging to diagnose or stage kidney tumors.

1 imaging visit (in-person) including intravenous administration of radioactive tracer and whole-body PET/CT scan

Trial Site Locations

Total: 1 location

1

Peking University Cancer Hospital

Beijing, Haidian, China, 10000

Actively Recruiting

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Research Team

L

Lei Xia

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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