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

February 15, 2024 updated by: YiHui Guan, Huashan Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

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 Locations

  • China
      • Shanghai, China, 200040
        • Recruiting
        • Huashan Hospital
        • Contact:

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:

  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 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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patients with renal cancer
Intravenous injection of 3.7 MBq [0.1 mCi]/kg of [18F]RCCB6 or [68Ga]Ga-NOTA-RCCB6 in a single dose
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
Experimental: patients with lymphoma
Intravenous injection of 3.7 MBq [0.1 mCi]/kg of [18F]RCCB6 or [68Ga]Ga-NOTA-RCCB6 in a single dose
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete PET imaging
Time Frame: 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.
90mins from time of injection

Collaborators and Investigators

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

Sponsor

Huashan Hospital

Investigators

  • Principal Investigator: Fang Xie, Huashan Hospital

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)

October 1, 2023

Primary Completion (Estimated)

June 13, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

November 19, 2023

First Submitted That Met QC Criteria

November 19, 2023

First Posted (Actual)

November 28, 2023

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2023-779

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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