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

NCT ID: NCT06203587

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-12-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

patients with colorectal cancer

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

1. Be between 18 and 65 years of age and of either sex.

2. Patients with colorectal cancer confirmed by puncture or surgical pathology.

3. Written informed consent signed by the subject or legal guardian or caregiver.

4. Willingness and ability to cooperate with all programs of this study.

Exclusion Criteria

1. Severe hepatic or renal insufficiency;

2. Targeted therapy before radiotherapy or PET/CT scan. Renal function: serum creatinine less than or equal to the upper limit of the normal range;

3. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huashan Hospital

OTHER

Sponsor Role: lead

Responsible Party

YiHui Guan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fang Xie, PhD

Role: PRINCIPAL_INVESTIGATOR

Huashan Hospital

Locations

Huashan Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yihui Guan, MD

Role: CONTACT

guanyihui@hotmail.com

13764308300 ext. +86

Facility Contacts

Yihui Guan, MD

Role: primary

guanyihui@hotmail.com

13764308300 ext. +86

Other Identifiers

KY2023-1016

Identifier Type: -

Identifier Source: org_study_id