A Study Evaluating the Value of 68Ga-NOTA-RCCB6 PET Imaging for Targeting CD70 in the Clinical Staging, Therapeutic Evaluation, and Restaging of Renal Cell Carcinoma, and Comparing It with 68Ga-PSMA PET/CT Imaging

January 7, 2025 updated by: Xijing Hospital

A Prospective, Open-label, Single-center Study of CD70-Specific PET/CT Imaging for Non-invasive Diagnosis of Renal Cell Carcinoma

This is a prospective, open-label, single-center clinical study targeting renal cell carcinoma. Sixty patients with a high clinical suspicion of renal cell carcinoma were included. Qualified subjects will undergo 68Ga-NOTA-RCCB6 PET/CT examination. The aim is to establish the optimal imaging protocol; evaluate the distribution characteristics and correlations of physiological and pathological positive uptake, and using pathological results as the gold standard, assess the diagnostic efficacy of 68Ga-NOTA-RCCB6 PET/CT in renal cell carcinoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This research process is divided into screening period, baseline period, safety visit period, and diagnostic efficacy follow-up period.

  1. Screening period (D-7 to D-1): No more than 7 days

    Screening is conducted within 7 days before the administration of 68Ga-NOTA-RCCB6 (D-7 to D-1). Before any study-related procedures, subjects must sign a written informed consent form. After signing the informed consent form, the following screening procedures are performed:

    ① Review of inclusion/exclusion criteria.

    • Collection of medical history, including but not limited to clinical data of the subjects and relevant auxiliary examination results (routine imaging examinations, tumor markers, biopsy results, etc.), numbering each subject and establishing a medical record.

      • Collection of demographic data (including gender, age, etc.). ④ Recording of concomitant medications/adverse events. If any inclusion criteria are not met or any exclusion criteria are met, the screening is considered failed.

  2. Baseline period (drug/administration period) (D0): 1 day Subjects who meet all inclusion criteria and do not meet any exclusion criteria will receive an injection of 68Ga-NOTA-RCCB6 and undergo a PET/CT scan on D0. The following assessments are performed again before administration, and only after a comprehensive evaluation by the doctor are they eligible for injection.

    • Concomitant medications after screening visit ② Weight

      • Vital signs

        • Adverse events Single dose, 0.05-0.1mCi/kg body weight, intravenous injection of 68Ga-NOTA-RCCB6 0.05-0.1mCi/kg PET/CT scan is performed 50-80 minutes after administration.

  3. Safety visit period (D0 to D4): 4 days

    • Follow-up on whether subjects have adverse reactions after administration.

      ② 2 hours ± 10 minutes after administration: monitoring of adverse events in subjects.

      ③ 1-4 days after administration: telephone follow-up to assess for delayed adverse events.

  4. Diagnostic efficacy follow-up period (D1 to D180): 6 months Follow-up on biopsy/surgical pathology results of subjects (preferably completed within 1 month after imaging) and imaging results to confirm the diagnostic efficacy of 68Ga-NOTA-RCCB6 PET/CT in renal cell carcinoma.

    When conducting diagnostic efficacy follow-up, the following should be recorded simultaneously: concomitant medications and adverse events.

  5. Withdrawal from study/premature termination of study

    If patients do not complete the PET examination according to the process, for subjects who withdraw prematurely, the following follow-up should be completed:

    ① Concomitant medications

    ② Adverse events

  6. Premature termination or suspension of study Reasons for study termination may include but are not limited to: new information on safety, requirements of the competent authorities. Other reasons include but are not limited to: excessive protocol violations, insufficient concern for subject safety, researcher turnover or insufficient staffing, etc.

In the event of any of the following situations during the study, the study may be terminated, and the competent authority should promptly report to the health department responsible for clinical research registration:

  • There is a violation of laws and regulations, rules;

    • There is a violation of ethical principles or the principles of scientific integrity;

      • During the study, it is found that the study drug may have serious quality defects; ④ Serious safety risks are found in clinical research;

        • There is commercial bribery or other improper interest relationships; ⑥ Other situations that should stop the study. For all situations where the study is suspended or terminated, appropriate steps will be taken to ensure the safety of the subjects.

Definition of study completion: PET imaging, result analysis, and necessary clinical follow-up of all study subjects have been completed.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, China, Shaanxi, China, 710000
        • Recruiting
        • Department ofNuclear Medicine,Xijing Hospital, Fourth Military Medical University, Xi'an, China
        • Contact:
        • Contact:
        • Contact:
          • Jing Wang, Chairman of CSNM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- The subject or legal guardian/caregiver must voluntarily sign the informed consent form.

Ages 18 to 75 years old. Patients with suspected renal cell carcinoma based on conventional imaging studies, and who undergo 68Ga-PSMA PET/CT scanning.

Patients with suspicious lymph nodes or distant metastases detected by conventional imaging or 68Ga-PSMA PET/CT.

Willing and able to follow the study protocol.

Exclusion Criteria:

- Patients who have received anti-tumor treatment prior to PET/CT scan. Suffer from severe other neurological diseases, or gastrointestinal, cardiovascular, liver, kidney, blood system, respiratory system, immunodeficiency and other serious diseases.

Alternative subjects have contraindications to PET/CT scanning. Including but not limited to: those who cannot tolerate repeated intravenous injections; those who may be allergic to the drug and its components (including those with a history of severe allergies or allergic reactions, especially those with allergies to the tested drug); claustrophobia.

In the past year, diagnosed with other malignant tumors; alternative subjects have undergone major surgery in the past 3 months; received experimental drug or device treatment with unclear effects or safety within the past month, or have participated in other interventional clinical trials.

Pregnant or lactating women. Patients who are lost to follow-up. Other conditions that, in the researcher's assessment, may affect the study or make the subject unsuitable for participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: before-after study in the same patient

This is a prospective, open-label, single-center clinical study for renal cell carcinoma.

Sixty patients clinically suspected of having renal cell carcinoma and undergoing 68Ga-PSMA PET scans were included.

Qualified subjects underwent 68Ga-NOTA-RCCB6 PET scans within 7 days after completing the 68Ga-PSMA PET scan. Patient medical history was collected and laboratory tests were performed before the examination, and a biopsy or surgery was performed to obtain pathological results within 1 month after the examination, followed by a 6-month follow-up. The pathological results were used as the diagnostic gold standard.
Diagnostic test: 68Ga-NOTA-RCCB6 PET/CT Scan

The imaging agent 68Ga-NOTA-RCCB6 used in this project is synthesized following the standards for radiopharmaceutical production, with reference to the Chinese Pharmacopoeia (quality standards for 18F-FDG). The pH value is between 5.0 and 8.0; the radiochemical purity is not less than 95%, and the bacterial endotoxin content in each milliliter of solution is less than 15EU; the radioactive concentration is not less than 37 MBq/mL; the solvent residues comply with the regulations.

Specification: 185~1850 MBq/ml Characteristics: Clear, colorless, no visible particles. Radioactive physical half-life: 68Ga is 68 minutes. Expiry: Calculated from the time of labeling, stable for 3 half-lives. Administration method: Intravenous injection. Dosage: 0.05-0.1mCi/kg, flush with 5 mL of saline after injection. The maximum mass dose of CD70 should not exceed 240ug, and the maximum volume of administration should not exceed 5 mL.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Standardized uptake value (SUVmax)
Time Frame: 1 day from injection of the tracer
Maximum Standardized uptake value (SUVmax) of [68Ga]RCCB6 and [68Ga]PSMA in the included subjects' primary and/or metastatic lesions.
1 day from injection of the tracer
Mean Standardized Uptake Value(SUVmean) of liver
Time Frame: 1 day from injection of the tracer
Mean Standardized uptake value (SUVmean) of [68Ga]RCCB6 and [68Ga]PSMA in the included subjects' liver.
1 day from injection of the tracer
Tumor to Background Ratio(TBR)
Time Frame: 1 day from injection of the tracer
TBR=SUVmax/SUVmean
1 day from injection of the tracer
The correlation between CD70 expression and [18F]RCCB6 uptake value
Time Frame: 30 days from injection of the tracer
The Standardized uptake value (SUV) of [68Ga]RCCB6 will be calculated, and the correlation between pathological results and tumor uptake of [68Ga]RCCB6 will be analyzed.
30 days from injection of the tracer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic value of 68Ga-NOTA-RCCB6 PET/CT in patients with RCC
Time Frame: 3-6 months from injection of the tracer
We will calculate the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy of 68Ga-NOTA-RCCB6 PET/CT in patients with RCC. We will also compare the diagnostic value of [68Ga]RCCB6 with [68Ga]PSMA. All the above goals will be achieved by analyzing the 68Ga-NOTA-RCCB6 PET/CT and 68Ga-PSMA PET/CT imaging data.
3-6 months from injection of the tracer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

November 7, 2025

Study Registration Dates

First Submitted

December 22, 2024

First Submitted That Met QC Criteria

January 7, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 7, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20242101-F-1
  • CHiCTR2400084782 (Other Identifier: Chinese Clinical Trial Registry)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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