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

NCT06769893 | Recruiting

• 2 other identifiers: KY20242101-F-1CHiCTR2400084782
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

RCC, Renal Cell Cancer

Keywords

Renal cell cancer; PSMA; The cluster of differentiation (CD70); Kidney tumor; ImmunoPET

Outcome Measures

Primary Outcomes (4)

• Maximum Standardized uptake value (SUVmax)

  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

  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)

  TBR=SUVmax/SUVmean

  1 day from injection of the tracer

• The correlation between CD70 expression and [18F]RCCB6 uptake value

  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 Outcomes (1)

• Diagnostic value of 68Ga-NOTA-RCCB6 PET/CT in patients with RCC

  3-6 months from injection of the tracer

Study Arms (1)

before-after study in the same patient

EXPERIMENTAL

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

Interventions

68Ga-NOTA-RCCB6 PET/CT Scan DIAGNOSTIC_TEST

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.

before-after study in the same patient

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Department ofNuclear Medicine,Xijing Hospital, Fourth Military Medical University, Xi'an, China

Xi'an, China, Shaanxi, 710000, China

RECRUITING

Related Links

• ChiCTR2400084782 registration number of the Chinese Clinical Trial Registry

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Ying Guo

CONTACT

0086+15991459177; guoying01192022@163.com

he rui Li

CONTACT

0086+17563734669; 3099595564@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: before-after study in the same patient

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: January 10, 2025
• Study Start: June 12, 2024
• Primary Completion: April 1, 2025
• Study Completion: November 7, 2025
• Last Updated: January 10, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)