NCT06148220

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 28, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

February 16, 2024

Status Verified

February 1, 2024

Enrollment Period

9 months

First QC Date

November 19, 2023

Last Update Submit

February 15, 2024

Conditions

Kidney CancerLymphomasPositron Emission Tomography

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

patients with renal cancer

EXPERIMENTAL

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

patients with lymphoma

EXPERIMENTAL

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

Interventions

[18F]RCCB6 and [68Ga]Ga-NOTA-RCCB6 PET/CT imagingRADIATION

Intravenous injection of 3.7 MBq \[0.1 mCi\]/kg of \[18F\]RCCB6 or \[68Ga\]Ga-NOTA-RCCB6 in a single dose

patients with lymphomapatients with renal cancer

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be between 18 and 65 years of age and of either sex.
  • Affected with renal cancer or lymphoma confirmed by puncture or surgical pathology.
  • Informed consent must be signed in writing by the subject or his/her legal guardian or caregiver.
  • Willingness and ability to cooperate with all programs of this study.

You may not qualify if:

  • Subjects meeting any of the following criteria will be excluded from the study:
  • Severe hepatic and renal insufficiency;
  • 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;
  • Liver function: bilirubin, AST(SGOT)/ALT(SGPT) less than or equal to the upper limit of the normal range.
  • History of serious surgery in the last month.
  • Those who have participated in other clinical trials during the same period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huashan Hospital

Shanghai, 200040, China

RECRUITING

Related Publications (1)

  • Zhou X, Wu Q, Zhai W, Zhang Y, Wu Y, Cao M, Wang C, Guan Y, Liu J, Xie F, Wei W. CD70-Targeted Immuno-PET/CT Imaging of Clear Cell Renal Cell Carcinoma: A Translational Study. J Nucl Med. 2024 Dec 3;65(12):1891-1898. doi: 10.2967/jnumed.124.268509.

    PMID: 39510586DERIVED

MeSH Terms

Conditions

Kidney NeoplasmsLymphoma

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Fang Xie

    Huashan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yihui Guan, MD

CONTACT

13764308300guanyihui@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 19, 2023

First Posted

November 28, 2023

Study Start

October 1, 2023

Primary Completion

June 13, 2024

Study Completion

September 1, 2024

Last Updated

February 16, 2024

Record last verified: 2024-02

Locations

CN(1)