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New PET scans to help detect kidney cancer (renal cell carcinoma)

Tests new PET scan tracers in people with renal cell carcinoma.

Key facts

Who runs it
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Where
Wuhan, ChinaSee the site
Trial code
Registry title
Study on the Diagnostic Value of Novel PET Molecular Imaging for Renal Cell Carcinoma
Status
Recruiting
People taking part
66 people, planned
Started
1 Jun 2025
Planned end
31 May 2026
Type of study
Interventional, 3 groups
Treatments tested
  • [68Ga]Ga-DOTA-CAIX peptide
  • [68Ga]Ga-NOTA-CD70 antibody fragment
  • [68Ga]Ga-PSMA
Record updated
24 December 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with suspected or confirmed kidney cancer (renal cell carcinoma), and also healthy volunteers, to test new PET scans.

Age
Tumor patients: 18 years or older. Healthy volunteers: 18-70 years.
Sex
Men and women can join.
Disease stage
Suspected or confirmed renal cell carcinoma, in good general condition.
Earlier treatment
Healthy volunteers must not have used any drugs, including herbal medicines, in the 2 weeks before the trial.

Main reasons for not taking part

  • Cannot complete a PET/MR or PET/CT scan (for example cannot lie flat, or fear of enclosed spaces)
  • Known allergy to the PSMA, CAIX or CD70 PET imaging agents
  • Pregnant or breastfeeding women
  • Fasting blood glucose above 11.0 mmol/L (198 mg/dL) before the [18F]FDG injection (tumor patients)
  • Healthy volunteers: serious medical condition, past or current cancer, or surgery in the last 6 months

The registry criteria, word for word

Show all 26 criteriaShow less

Who can take part

  • Tumor subjects:
  • The subject or his/her legal representative is able to sign the informed consent form signed and dated
  • Promise to abide by the research procedures and cooperate with the implementation of the whole process of research
  • Adult subjects (aged 18 years or above), male or female
  • Patients with clinically suspected or confirmed renal cell carcinoma (supporting evidence includes serum-related tumor markers, ultrasound, CT, MRI and other imaging data and histopathological examinations, etc.), and are in good general condition
  • Conform to specific laboratory test results
  • Contraception for at least one month before screening for females in the childbearing period, and commitment to use contraception throughout the study period and continue until the specified time after the end of the study
  • Other set selection criteria; Healthy Subjects:
  • Fully understand and voluntarily sign the informed consent form
  • Male or female, age 18-70 years old
  • Male weight >=50.0kg, female weight >=45.0kg; Body mass index (BMI) within the range of 19.0~26.0kg/m\^2 (including the cut-off value)
  • No history of chronic or serious diseases such as cardiovascular, liver, kidney, respiratory, blood and lymphatic, endocrine, immunologic, psychiatric, neuromuscular, gastrointestinal system, etc., within three years, and in good general health
  • There is no abnormality in vital signs examination and physical examination
  • Have no fertility plan during the trial and within 6 months after the end of the trial and voluntarily take effective contraceptive measures and have no sperm and egg donation plans
  • Able to communicate well with the investigator, and understand and comply with the requirements of the study

Who cannot take part

  • Any serious or unstable medical condition; Those who have acute illness before the study; Previous or existing malignancy
  • Those who have undergone surgery within 6 months before the trial, which is judged by the investigator to affect absorption, distribution, metabolism, and excretion
  • Those who have used any drugs (including prescription drugs, over-the-counter drugs, and Chinese herbal medicines) within 2 weeks before the trial
  • Patients with known hypersensitivity to targeted PSMA, CAIX or CD70 PET imaging agents or synthetic excipients; The fasting blood glucose level before injection of [18F]FDG exceeded 11.0 mmol/L
  • Tumor subjects:
  • Those who are unable to complete PET/MR or PET/CT examination (including inability to lie flat, claustrophobia, radiophobia, etc.)
  • Patients who are pregnant or lactating
  • Those who have other factors that are not suitable for participating in this test; Healthy Subjects:
  • Pregnant and lactating women
  • Participation in other research studies involving radioactive materials (within the past 12 months)
  • Any other factors that affect the results of the study

Where in China

  • Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaContact: Xiaoli LanTaking people

About the trial

What the trial wants to find out

This study is a diagnostic study. This project aims to explore the clinical application value of PET imaging technologies targeting PSMA, CAIX, and CD70 in renal cell carcinoma. By utilizing PSMA-targeted PET radiopharmaceuticals (e.g., [⁶⁸Ga]Ga-PSMA), CAIX-targeted PET radiopharmaceuticals (e.g., [⁶⁸Ga]Ga-DOTA-CAIX), and CD70-targeted PET radiopharmaceuticals (e.g., [⁶⁸Ga]Ga-NOTA-CD70 antibody fragment) in patients with clinically suspected or confirmed renal cell carcinoma and healthy volunteers, we will investigate their diagnostic and therapeutic potential. [⁶⁸Ga]Ga-DOTA-CAIX peptide as an example), and a PET imaging agent targeting CD70 ([⁶⁸Ga]Ga-NOTA-CD70 antibody fragment as an example) in patients with clinically suspected or confirmed renal cell carcinoma and healthy volunteers. Integrated PET/MR or PET/CT imaging will be performed to aid in the diagnosis and staging of renal cell carcinoma, assess tumor burden and the expression levels of PSMA, CAIX, and CD70, and assist in determining treatment strategies. Concurrently, preliminary pharmacokinetic analysis of the novel CAIX-targeting molecular probe will be conducted in healthy volunteers to elucidate its metabolic patterns and adverse reactions in vivo.

The 3 groups in the trial

  • PET imaging targeting CAIX in renal cell carcinomaTreatment being tested

    Treatment: [68Ga]Ga-DOTA-CAIX peptide

  • PET imaging targeting PSMA in renal cell carcinomaTreatment being tested

    Treatment: [68Ga]Ga-PSMA

  • PET imaging targeting CD70 in renal cell carcinomaTreatment being tested

    Treatment: [68Ga]Ga-NOTA-CD70 antibody fragment

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Study on the Diagnostic Value of Novel PET Molecular Imaging for Renal Cell Carcinoma
Plain-language title
New PET scans to help detect kidney cancer (renal cell carcinoma)Generated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
24 December 2025