A Study of [68Ga]Ga-NOTA-RG2 PET Imaging in the Diagnosis... | NCT06148155

Studies
A Study of [68Ga]Ga-NOTA-RG2 PET Imaging in the Diagnosis of Hepatocellular Carcinoma

NCT06148155

Sponsor

Huashan Hospital

Status

Unknown status

Last Update Posted

Feb 16, 2024Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Hepatocellular Carcinoma

Interventions

[68Ga]Ga-NOTA-RG2 PET Imaging

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

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2023Actual

Primary Completion Date

Mar 1, 2024Estimated

Completion Date

Jun 1, 2024Estimated

First Submitted Date

Nov 19, 2023

First Submission Date that Met QC Criteria

Nov 19, 2023

First Posted Date

Nov 28, 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

Feb 15, 2024

Last Update Posted Date

Feb 16, 2024Actual

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
[68Ga]Ga-NOTA-RG2 PET Imaging	Radiation	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)

Measure	Description	Time Frame
Complete PET imaging	To assess the sensitivity and specificity of diagnosing HCC using [68Ga]Ga-NOTA-RG2.	90mins from time of injection

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Subjects meeting any of the following criteria will be excluded from the study:
1. Patients receiving anti-tumor therapy prior to the PET/CT scan.
2. Suffering from severe other neurological disorders, or gastrointestinal, cardiovascular, hepatic, renal, hematologic, respiratory, immunodeficiency, and other serious diseases.
3. 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.
4. 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.
5. Alternative subjects have undergone major surgery within the last 3 months; experimental drug or device therapy (of uncertain efficacy or safety) within 1 month
6. 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

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