NCT04542863

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 9, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

September 11, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

4 years

First QC Date

September 2, 2020

Last Update Submit

March 27, 2023

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

  • Standard 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 18F-DX600 PET/CT scans.

Other: 18F-DX600 PET/CT

Interventions

18F-DX600 PET/CTOTHER

DX600, labeled with 18F will be used as a molecular imaging tracer for PET/CT scanning

Imaging cohort

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>3 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Central Study Contacts

Hua Zhu

CONTACT

010-88196495zhuhuabch@pku.edu.cn

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

September 2, 2020

First Posted

September 9, 2020

Study Start

September 11, 2020

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

March 29, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)