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

NCT04422457 | Completed

• 1 other identifier: 2020KT62
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• SUV

  The uptake of uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value（SUV）

  2 years

Study Arms (1)

Imaging cohort

EXPERIMENTAL

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

Other: 68Ga-DX600 PET/CT

Interventions

68Ga-DX600 PET/CT OTHER

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

Imaging cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Ethics Committee of Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Related Publications (1)

• Zhang Q, Liu T, Ding J, Zhou N, Yu Z, Ren Y, Qin X, Du P, Yang Z, Zhu H. Evaluation of 68Ga- and 177Lu-Labeled HZ20 Angiotensin-Converting Enzyme 2-Targeting Peptides for Tumor-Specific Imaging. Mol Pharm. 2022 Nov 7;19(11):4149-4156. doi: 10.1021/acs.molpharmaceut.2c00541. Epub 2022 Oct 5.

  PMID: 36198565 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 9, 2020
• Study Start: June 13, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)