NCT06148155

Brief Summary

The aim of this study was to establish and optimize the imaging method of \[68Ga\]Ga-NOTA-RG2, as well as its physiological and pathological distribution characteristics, and on this basis to evaluate the diagnostic efficacy of the above imaging agents in patients with hepatocellular carcinoma.

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 hepatocellular-carcinoma

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable hepatocellular-carcinoma

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

June 1, 2023

Completed
6 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
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 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

Hepatocellular Carcinoma

Keywords

Hepatocellular CarcinomaPositron-Emission Tomography

Outcome Measures

Primary Outcomes (1)

  • Complete PET imaging

    To assess the sensitivity and specificity of diagnosing HCC using \[68Ga\]Ga-NOTA-RG2.

    90mins from time of injection

Study Arms (1)

patients with primary and/or metastatic hepatocellular carcinoma (HCC)

EXPERIMENTAL

The diagnosis of HCC is established by surgery or biopsy pathology.

Radiation: [68Ga]Ga-NOTA-RG2 PET Imaging

Interventions

[68Ga]Ga-NOTA-RG2 PET ImagingRADIATION

Intravenous injection of 1.8 MBq \[0.05MCi\]/kg of \[68Ga\]Ga-NOTA-RG2 in a single dose.

patients with primary and/or metastatic hepatocellular carcinoma (HCC)

Eligibility Criteria

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

You may qualify if:

  • Hepatocellular carcinoma patients
  • Age between 18 and 65 years old, gender is not limited.
  • Patients with suspicious intrahepatic spaces detected by MR and considered to be hepatocellular carcinoma with AFP\>200 ug/L who have not undergone surgery.
  • Patients with hepatocellular carcinoma confirmed by puncture pathology
  • Written informed consent must be signed by the subject or his/her legal guardian or caregiver.
  • Willingness and ability to cooperate with all programs of the study.

You may not qualify if:

  • Subjects meeting any of the following criteria will be excluded from the study:
  • Patients receiving anti-tumor therapy prior to the PET/CT scan.
  • Suffering from severe other neurological disorders, or gastrointestinal, cardiovascular, hepatic, renal, hematologic, respiratory, immunodeficiency, and other serious diseases.
  • Alternative subjects with conditions that contraindicate PET/CT scanning. This includes, but is not limited to, elevated blood glucose that is not effectively controlled; pregnant, lactating, or breastfeeding women; those who are unable to receive repeated intravenous injections; those who may be hypersensitive to the drug and its components (including a history of severe allergies or anaphylactic reactions, especially to the drug being examined); and hermetic phobias.
  • Within the past year, have participated in other research protocols or clinical care, in addition to the radiation exposure expected from participation in this clinical study, which has resulted in radiation exposure in excess of an effective dose of 50 mSv.
  • Alternative subjects have undergone major surgery within the last 3 months; experimental drug or device therapy (of uncertain efficacy or safety) within 1 month
  • The alternate subject has any clinical condition that, in the opinion of the Sponsor of this study, may cause or has the potential to cause harm from this agent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huashan Hospital

Shanghai, 200040, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Officials

  • Fang Xie, PhD

    Huashan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yihui Guan

CONTACT

+8613764308300guanyihui@hotmail.com

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
Professor

Study Record Dates

First Submitted

November 19, 2023

First Posted

November 28, 2023

Study Start

June 1, 2023

Primary Completion

March 1, 2024

Study Completion

June 1, 2024

Last Updated

February 16, 2024

Record last verified: 2024-02

Locations

CN(1)