A Study of the Clinical Application of [18F]RCCB6 and [68Ga]Ga-NOTA-RCCB6 PET/CT Imaging in the Diagnosis of CD70-expressing Multiple Tumors

Kidney Cancer Clinical Trial

Official title:

A Study of the Clinical Application of [18F]RCCB6 and [68Ga]Ga-NOTA-RCCB6 PET/CT Imaging in the Diagnosis of CD70-expressing Multiple Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06148220
• Other study ID #: KY2023-779
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: February 2024
• Source: Huashan Hospital
• Contact: Yihui Guan, MD
• Phone: 13764308300
• Email: guanyihui[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to establish and optimize the [18F]RCCB6 and [68Ga]Ga-NOTA-RCCB6 PET/CT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agents in renal cancer (especially clear cell renal cell carcinoma) and lymphoma was evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 1, 2024
• Est. primary completion date: June 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Be between 18 and 65 years of age and of either sex.

2. Affected with renal cancer or lymphoma confirmed by puncture or surgical pathology.

3. Informed consent must be signed in writing by the subject or his/her legal guardian or caregiver.

4. Willingness and ability to cooperate with all programs of this study.

Exclusion Criteria:

• Subjects meeting any of the following criteria will be excluded from the study:

1. Severe hepatic and renal insufficiency;

2. Targeted therapy prior to radiotherapy or PET/CT scan. Renal function: serum creatinine less than or equal to the upper limit of the normal range;

3. Liver function: bilirubin, AST(SGOT)/ALT(SGPT) less than or equal to the upper limit of the normal range.

4. History of serious surgery in the last month.

5. Those who have participated in other clinical trials during the same period.

Related Conditions & MeSH terms

• Kidney Cancer
• Kidney Neoplasms
• Lymphomas
• Positron Emission Tomography

Intervention

Radiation:
• [18F]RCCB6 and [68Ga]Ga-NOTA-RCCB6 PET/CT imaging
Intravenous injection of 3.7 MBq [0.1 mCi]/kg of [18F]RCCB6 or [68Ga]Ga-NOTA-RCCB6 in a single dose

Locations

Country	Name	City	State
China	Huashan Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete PET imaging	1. Establishment and optimization of imaging method for [18F]RCCB6 or [68Ga]Ga-NOTA-RCCB6 PET/CT imaging. 2. Evaluating the sensitivity and specificity of using [18F]RCCB6 or [68Ga]Ga-NOTA-RCCB6 PET/CT in diagnosing renal cell carcinoma (especially metastatic clear cell renal carcinoma) and lymphoma.	90mins from time of injection