Construction and Clinical Translation of ACE Targeted Nuclear Medicine Imaging Probe

August 16, 2024 updated by: Hua Zhu, Peking University Cancer Hospital & Institute
This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the clinical predictive value of 68Ga-DOTA-BPP in subjects with triple-negative breast cancer. The visual and semiquantitative methods will be used to assess the PET/CT images

Study Overview

Status

Recruiting

Conditions

Detailed Description

ACE is expressed in triple-negative breast cancer cells. This project develops new type of 68GA-labeled DOTA-BPP, leveraging the inherent strengths of this nuclear medicine discipline, promoted the formulation of the production of this drug To obtain 68Ga-DOTA-BPP injection that can be used in preclinical studies and meets clinical standards. Join a group In clinical patients, 68Ga-DOTA-BPP PET/CT imaging of patients with ACE-positive TNBC was performed, and ACE was obtained To provide evidence for patient screening and efficacy evaluation before targeted therapy with high expression of TNBC, and preliminatively evaluate the level of ACE against high level of ACE. The effect of tumor development can provide a practical basis for the establishment of ACE-targeted PET imaging platform

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Ethics Committee of Peking University Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients at Being Cancer Hospital who are confirmed TNBC.

Description

Inclusion Criteria:

  1. 18-75 years old;
  2. ECOG score 0 or 1 point;
  3. Participants with confirmed TNBC cancer who are suggested by the clinicians to conduct PET/CT imaging for tumor diagnosis or staging.

Exclusion Criteria:

  1. Pregnant or nursing;
  2. Severe hepatic or renal dysfunction;
  3. Low WBC (less than 3 x 10^9/L);
  4. Unable to comply with the PET/CT imaging procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
68Ga-DOTA-BPP
68Ga-DOTA-BPP PET/CT: after intravenous injection of 2.96 MBq/ kg body weight of quality-controlled 68Ga-DOTA-BPP, a Siemens Biograph PET/CT scan will be applied within 1 h-2 h, and the scan range will be from the top of the head to 1/3 of the upper thigh.
18F-FGD
18F-FDG PET/CT: after intravenous injection of 2.96 MBq/ kg body weight of quality-controlled 18F-FDG, a Siemens Biograph PET/CT scan will be applied within 1 h, and the scan range will be from the top of the head to 1/3 of the upper thigh.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual assessment of lesions
Time Frame: 1 year
Visual analysis of 68Ga-DOTA-BPP PET images will be performed by consensus reading by at least 2 experienced nuclear medicine physician
1 year
Semiquantitative assessment of lesions
Time Frame: 1 year
The standardized uptake values (SUVs) of 68Ga-DOTA-BPP in lesions will be measured by the same nuclear medicine physician for all the cases
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ACE expression analysis of tumor tissues
Time Frame: 1 year
Tumor tissues obtained from biopsy or surgery will be stained for ACE
1 year
Correlation analysis of 68Ga-DOTA-BPP uptake and lesion size changes
Time Frame: 1 year
The SUVs of 68Ga-DOTA-BPP in individual lesions will be compared to the changes in lesion sizes
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Cancer Hospital & Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

January 2, 2024

First Submitted That Met QC Criteria

January 2, 2024

First Posted (Actual)

January 12, 2024

Study Record Updates

Last Update Posted (Actual)

August 19, 2024

Last Update Submitted That Met QC Criteria

August 16, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023KT160

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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