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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06203587
Other study ID # KY2023-1016
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2023
Est. completion date December 1, 2024

Study information

Verified date February 2024
Source Huashan Hospital
Contact Yihui Guan, MD
Phone 13764308300
Email guanyihui@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 1, 2024
Est. primary completion date September 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Radiation:
[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.

Locations

Country Name City State
China Huashan Hospital Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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