Specific Molecular Imaging of DX600 Labeled by PET Radionuclide Targeting ACE2 in Patients

Not Applicable

Completed

• Conditions: Solid Tumor
• Interventions: Other: 68Ga-DX600 PET/CT

• Registration Number: NCT04422457
• Lead Sponsor: Peking University Cancer Hospital & Institute

Brief Summary

Angiotensin-converting enzyme 2 (ACE2) plays an important role in renin-angiotensin system (RAS) and has been reported to relate with cancer. Recently, it has also been proved as the key target for COVID-19 infection.

DX600 is a polypeptide that can specific binding to ACE2 specifically with nanomolar affinity reported in literature. This study constrcuted a radio-tracer, DX600 Labeled by PET Radionuclide, to monitoring biodistribution ACE2 in human beings, evaluate the detection ability of radio-tracer in ACE2 over-expression tumors and dynamic changes of ACE2 expression under therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-05
• Study First Submitted QC: 2020-06-05
• Study First Posted: 2020-06-09
• Study Start: 2020-06-13
• Primary Completion: 2022-03-01
• Study Completion: 2022-03-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Age 18-75 years old; both sex;
• ECoG 0 or 1;
• Patients that would undergo biopsy or surgical operation with high ACE2 expression tumors such as colorectal cancer, renal cancer, pancreatic cancer, gastric cancer, liver cancer, lung cancer, brain cancer or suspected tumor.
• use 18F-FDG PET/CT as baseline evaluation

Exclusion Criteria

• Significant hepatic or renal dysfunction;
• Is Pregnant or ready to pregnant;
• Cannot lie on their back for half an hour;
• Suffering from claustrophobia or other mental diseases;
• Refusal to join the clinical study;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Imaging cohort	68Ga-DX600 PET/CT	All study participants will be allocated to this arm (single-arm study).Study participants will undergo 68Ga-DX600 PET/CT scans

Primary Outcome Measures

Name	Time	Method
SUV	2 years	The uptake of uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value（SUV）

Trial Locations

Locations (1)

Ethics Committee of Peking University Cancer Hospital; 🇨🇳 Beijing, Beijing, China