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

Clinical Trial Summary

This study will investigate the safety and preliminary diagnostic efficacy of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 in pancreatic cancer, breast cancer, head and neck cancer, lung cancers and other types of solid tumors. Then, this study will provide a new method for the noninvasive target-specific diagnosis of pancreatic cancer, breast cancer, head and neck cancer, lung cancers and other types of solid tumors. PET imaging of TROP-2 will be integrated to TROP-2-targeted therapies in some of the included patients. Therefore, PET imaging with [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 will help select patients for targeted therapy and monitor treatment responses after the 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:
• [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4
The dose of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-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 safety and feasibility of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT imaging in patients with solid tumors	The primary goal of the study is to evaluate the distribution profiles (in terms of SUVmax) of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT imaging in patients with solid tumors.	1 hour after injection of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4
Primary	evaluate the sensitivity and specificity of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT for visualizing TROP-2 expression	The secondary goal is to evaluate the sensitivity and specificity of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT for visualizing TROP-2 expression.	1 hour after injection of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4
Primary	evaluate the value of TROP-2 expression determined by [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT	The third goal is to evaluate the value of TROP-2 expression determined by [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT in differential diagnosis, patient selection, and response monitoring in patients with solid tumors.	1 hour after injection of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4