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

Not Applicable

Recruiting

• Conditions: Kidney Cancer; Lymphomas; Positron Emission Tomography
• Interventions: Radiation: [18F]RCCB6 and [68Ga]Ga-NOTA-RCCB6 PET/CT imaging

• Registration Number: NCT06148220
• Lead Sponsor: Huashan Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-01
• Study First Submitted: 2023-11-19
• Study First Submitted QC: 2023-11-19
• Study First Posted: 2023-11-28
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-16
• Primary Completion: 2024-06-13
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients with renal cancer	[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
patients with lymphoma	[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

Primary Outcome Measures

Name	Time	Method
Complete PET imaging	90mins from time of injection	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.

Trial Locations

Locations (1)

Huashan Hospital; 🇨🇳 Shanghai, China