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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04422457
• Other study ID #: 2020KT62
• Status: Completed
• Phase: N/A
• Start date: June 13, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: July 2022
• Source: Beijing Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Solid Tumor

Intervention

Other:
• 68Ga-DX600 PET/CT
DX600, labeled with 68Ga will be used as a molecular imaging tracer for PET/CT scanning

Locations

Country	Name	City	State
China	Ethics Committee of Peking University Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SUV	The uptake of uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value(SUV)	2 years