Clinical Study of GPA33-specific PET/CT for the Diagnosis of Colorectal Cancer

NCT06203587 | Recruiting DMC

• 1 other identifier: KY2023-1016
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, we will first investigate the imaging safety and feasibility of \[68Ga\]Ga-NOTA-WWH347 and \[18F\]F-H3RESCA-WWH347 PET/CT in patients with primary and/or metastatic colorectal cancers. The second goal of the study is to preliminarily investigate the diagnostic efficacy (e.g., sensitivity and specificity) of \[68Ga\]Ga-NOTA-WWH347 and \[18F\]F-H3RESCA-WWH347 PET/CT in patients with primary and/or metastatic colorectal cancers. This study will provide a new method for the noninvasive target-specific diagnosis of colorectal cancer, and provide an intuitive and clear imaging basis for clinical diagnosis, differential diagnosis and treatment.

Conditions

Positron-Emission Tomography; Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Establishment and optimization of imaging method for [68Ga]Ga-NOTA-WWH347 or [18F]F-H3RESCA-WWH347 PET/CT.

  To assess the safety, sensitivity and specificity of diagnosing colorectal cancer using \[68Ga\]Ga-NOTA-WWH347 or \[18F\]F-H3RESCA-WWH347 PET/CT.

  90mins from time of injection

Study Arms (1)

patients with colorectal cancer

EXPERIMENTAL

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

Radiation: [68Ga]Ga-NOTA-WWH347 or [18F]F-H3RESCA-WWH347

Interventions

[68Ga]Ga-NOTA-WWH347 or [18F]F-H3RESCA-WWH347 RADIATION

The dose of \[68Ga\]Ga-NOTA-WWH347 or \[18F\]F-H3RESCA-WWH347, calculated from the patient's body weight, was 1.8-3.7 MBq \[0.05-0.1 mCi\]/kg, and was administered as an intravenous push, with a single dose given once.

patients with colorectal cancer

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be between 18 and 65 years of age and of either sex.
• Patients with colorectal cancer confirmed by puncture or surgical pathology.
• Written informed consent signed by the subject or legal guardian or caregiver.
• Willingness and ability to cooperate with all programs of this study.

You may not qualify if:

• Severe hepatic or renal insufficiency;
• Targeted therapy before radiotherapy or PET/CT scan. 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.
• History of serious surgery in the last month.
• Those who have participated in other clinical trials during the same period.

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Fang Xie, PhD

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yihui Guan, MD

CONTACT

13764308300; guanyihui@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: 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 20, 2024

Record last verified: 2024-02

Locations

CN (1)