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

NCT ID: NCT06203574

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-12-01

Brief 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.

Conditions

Positron-Emission Tomography; Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

patients with solid tumors

Subjects were recruited from Huashan Hospital of Fudan University.

Group Type: EXPERIMENTAL

[68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4

Intervention Type: RADIATION

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.

Interventions

[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.

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huashan Hospital

OTHER

Sponsor Role: lead

Responsible Party

YiHui Guan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fang Xie, PhD

Role: PRINCIPAL_INVESTIGATOR

Huashan Hospital

Locations

Huashan Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yihui Guan, MD

Role: CONTACT

guanyihui@hotmail.com

13764308300 ext. +86

Facility Contacts

Yihui Guan, MD

Role: primary

guanyihui@hotmail.com

13764308300 ext. +86

Other Identifiers

KY2023-1017

Identifier Type: -

Identifier Source: org_study_id