NCT05681234

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

August 24, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 27, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
Last Updated

January 12, 2023

Status Verified

December 1, 2022

Enrollment Period

2 months

First QC Date

December 27, 2022

Last Update Submit

December 27, 2022

Conditions

Liver Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

18F-RD2

EXPERIMENTAL
Radiation: 18F-RD2

Interventions

18F-RD2RADIATION

Patients will receive 5-10 mCi 18F-RD2

18F-RD2

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, 214000, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Design

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

Study Record Dates

First Submitted

December 27, 2022

First Posted

January 12, 2023

Study Start

August 24, 2022

Primary Completion

November 2, 2022

Study Completion

December 20, 2022

Last Updated

January 12, 2023

Record last verified: 2022-12

Locations

CN(1)