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

Not Applicable

Recruiting

• Conditions: Colorectal Neoplasms; Positron-Emission Tomography
• Interventions: Radiation: [68Ga]Ga-NOTA-WWH347 or [18F]F-H3RESCA-WWH347

• Registration Number: NCT06203587
• Lead Sponsor: Huashan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-01
• Study First Submitted: 2024-01-03
• Study First Submitted QC: 2024-01-03
• Study First Posted: 2024-01-12
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20
• Primary Completion: 2024-09-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients with colorectal cancer	[68Ga]Ga-NOTA-WWH347 or [18F]F-H3RESCA-WWH347	Subjects were recruited from the Department of Gastroenterology, Huashan Hospital, Fudan University, Shanghai, China.

Primary Outcome Measures

Name	Time	Method
Establishment and optimization of imaging method for [68Ga]Ga-NOTA-WWH347 or [18F]F-H3RESCA-WWH347 PET/CT.	90mins from time of injection	To assess the safety, sensitivity and specificity of diagnosing colorectal cancer using \[68Ga\]Ga-NOTA-WWH347 or \[18F\]F-H3RESCA-WWH347 PET/CT.

Trial Locations

Locations (1)

Huashan Hospital; 🇨🇳 Shanghai, China