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

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.

Study Overview

• Status: Recruiting
• Conditions: Neoplasms; Positron-Emission Tomography
• Intervention / Treatment: Radiation: [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yihui Guan, MD; Phone Number: +86 13764308300; Email: guanyihui@hotmail.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Huashan Hospital
    • Contact: Yihui Guan, MD; Phone Number: +86 13764308300; Email: guanyihui@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients with solid tumors; Subjects were recruited from Huashan Hospital of Fudan University.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Huashan Hospital
• Investigators: Principal Investigator: Fang Xie, PhD, Huashan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 3, 2024
• First Submitted That Met QC Criteria: January 3, 2024
• First Posted (Actual): January 12, 2024

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: June 14, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: KY2023-1017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No