NCT06203613

Brief Summary

In this study, we will investigate the diagnostic efficacy and safety of \[18F\]F-H3RESCA-3A12 and \[68Ga\]Ga-NOTA-3A12 in metastatic gastric and pancreatic cancers, and evaluate the sensitivity and specificity of the use of \[18F\]F-H3RESCA-3A12 and \[68Ga\]Ga-NOTA-3A12 for diagnosing metastatic gastric and pancreatic cancers . This study will provide a new method for the noninvasive target-specific diagnosis of gastric and pancreatic cancer, and provide intuitive and clear imaging basis for clinical diagnosis, differential diagnosis and treatment.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 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

December 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 3, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

February 16, 2024

Status Verified

February 1, 2024

Enrollment Period

9 months

First QC Date

January 3, 2024

Last Update Submit

February 15, 2024

Conditions

Positron Emission TomographyPancreatic NeoplasmsIgestive System Neoplasms

Outcome Measures

Primary Outcomes (1)

  • To assess the sensitivity and specificity of using [18F]F-H3RESCA-3A12 and [68Ga]Ga-NOTA-3A12 for the diagnosis of metastatic gastric and pancreatic cancer

    In this study, we will first investigate the safety and feasibility of \[18F\]F-H3RESCA-3A12 and \[68Ga\]Ga-NOTA-3A12 in metastatic gastric and pancreatic cancers. The secondary goal of the clinical trial is to preliminary assess the sensitivity and specificity of using \[18F\]F-H3RESCA-3A12 or \[68Ga\]Ga-NOTA-3A12 PET/CT imaging for the diagnosis of metastatic gastric or pancreatic cancers.

    90mins from time of injection

Study Arms (2)

patients with gastric cancer

EXPERIMENTAL

Subjects were recruited from the Department of General Surgery, Huashan Hospital, Fudan University, Shanghai, China.

Radiation: [18F]F-H3RESCA-3A12及[68Ga]Ga-NOTA-3A12

patients with pancreatic cancer

EXPERIMENTAL

Subjects were recruited from the Department of General Surgery, Huashan Hospital, Fudan University, Shanghai, China.

Radiation: [18F]F-H3RESCA-3A12及[68Ga]Ga-NOTA-3A12

Interventions

[18F]F-H3RESCA-3A12及[68Ga]Ga-NOTA-3A12RADIATION

The dose of \[18F\]RCCB6 was calculated based on the patient's body weight to be 3.7 MBq \[0.1 MCi\]/kg, and the method of administration was intravenous push, with a single visualization administered once.

patients with gastric cancerpatients with pancreatic cancer

Eligibility Criteria

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

You may qualify if:

  • (1) Age between 18 and 65 years old, gender is not limited. (2) Patients with gastric or pancreatic cancer confirmed by puncture or surgical pathology.
  • (3) Written informed consent signed by the subject or his/her legal guardian or caregiver.
  • (4) Willingness and ability to cooperate with all programs of this study.

You may not qualify if:

  • \- (1) Severe hepatic or renal insufficiency; (2) Targeted therapy before radiotherapy or PET/CT scan. (3)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.
  • (4) History of serious surgery in the last month. (5) Those who have participated in other clinical trials during the same period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PET Center, Huashan Hospital, Fudan University

Shanghai, 200235, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Fang Xie, PhD

    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
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 3, 2024

First Posted

January 12, 2024

Study Start

December 1, 2023

Primary Completion

September 1, 2024

Study Completion

December 1, 2024

Last Updated

February 16, 2024

Record last verified: 2024-02

Locations

CN(1)