Clinical Study of TROP-2 PET/CT for Noninvasive Diagnosis of Solid Tumors

Neoplasms Clinical Trial

Official title:

Clinical Study of TROP-2 PET/CT for Noninvasive Diagnosis of Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06203574
• Other study ID #: KY2023-1017
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: January 2024
• Source: Huashan Hospital
• Contact: Yihui Guan, MD
• Phone: 13764308300
• Email: guanyihui[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, we will investigate the diagnostic efficacy and safety of [18F]F/[68Ga]Ga-NOTA-T4 in pancreatic cancer, breast cancer, or head and neck malignant tumors, and evaluate the sensitivity and specificity of using [18F]F/[68Ga]Ga-NOTA-T4 for diagnosing HCC. This study will provide a new method for the noninvasive target-specific diagnosis of pancreatic cancer, breast cancer, or head and neck malignant tumors, and provide an intuitive and clear imaging basis for clinical diagnosis, differential diagnosis, and treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• 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;

3. 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;

4. History of serious surgery in the last month. Those who have participated in other clinical trials during the same period.

Related Conditions & MeSH terms

• Neoplasms
• Positron-Emission Tomography

Intervention

Radiation:
• [18F]F/[68Ga]Ga-NOTA-T4
The dose of [18F]F/[68Ga]Ga-NOTA-T4 was calculated based on the patient's body weight to be 3.7 MBq [0.1 MCi]/kg, and the method of administration was intravenous push, with one single imaging administration.

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	evaluate the sensitivity and specificity of using [18F]F/[68Ga]Ga-NOTA-T4 for diagnosing HCC	In this study, we will investigate the diagnostic efficacy and safety of [18F]F/[68Ga]Ga-NOTA-T4 in pancreatic cancer, breast cancer, or head and neck malignant tumors	90mins from time of injection