Clinical Application of 18F-labeled RD2 PET/CT Imaging in... | NCT05681234

Studies
Clinical Application of 18F-labeled RD2 PET/CT Imaging in the Diagnosis and Treatment of Small Liver Carcinoma

NCT05681234

Sponsor

Affiliated Hospital of Jiangnan University

Status

Completed

Last Update Posted

Jan 12, 2023Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Liver Carcinoma

Interventions

18F-RD2

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 24, 2022Actual

Primary Completion Date

Nov 2, 2022Actual

Completion Date

Dec 20, 2022Actual

First Submitted Date

Dec 27, 2022

First Submission Date that Met QC Criteria

Dec 27, 2022

First Posted Date

Jan 12, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 27, 2022

Last Update Posted Date

Jan 12, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chunjing Yu, Director, Affiliated Hospital of Jiangnan UniversityPrincipal Investigator

Lead Sponsor

Affiliated Hospital of Jiangnan UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a single arm study to evaluate the safety and biodistribution of 18F-labeled RD2 PET/CT Imaging in patients with small liver carcinoma.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
18F-RD2	Experimental		Radiation: 18F-RD2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
18F-RD2	Radiation	Patients will receive 5-10 mCi 18F-RD2	18F-RD2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of tissue distribution of 18F-RD2	Biodistribution of 18F-RD2 evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 18F-RD2 scans will be reported.	2 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with highly suspected tumor；
Patients underwent PET/CT examination within 1 week;
Patients voluntarily signed informed consent;
Over 18 years old, male or female.

Exclusion Criteria:

Pregnant women;
Lactating women;
Patients with impaired renal function.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Affiliated Hospital of Jiangnan University		Wuxi	Jiangsu	214000	China

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided