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

Fudan University

Status: Enrolling

Conditions: Colorectal Neoplasms; Positron-Emission Tomography

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06203587

KY2023-1016

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

patients with colorectal cancer

Experimental group

Description:

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

Treatment:

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