Construction and Clinical Translation of ACE Targeted Nuclear Medicine Imaging Probe

Cancer Clinical Trial

Official title:

Construction and Clinical Translation of ACE Targeted Nuclear Medicine Imaging Probe

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06203119
• Other study ID #: 2023KT160
• Status: Recruiting
• Start date: October 1, 2022
• Est. completion date: October 2024

Study information

• Verified date: January 2024
• Source: Peking University Cancer Hospital & Institute
• Contact: Qian Zhang
• Phone: 13765839835
• Email: 1806708691[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Cancer Hospital & Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual assessment of lesions	Visual analysis of 68Ga-DOTA-BPP PET images will be performed by consensus reading by at least 2 experienced nuclear medicine physician	1 year
Primary	Semiquantitative assessment of lesions	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	ACE expression analysis of tumor tissues	Tumor tissues obtained from biopsy or surgery will be stained for ACE	1 year
Secondary	Correlation analysis of 68Ga-DOTA-BPP uptake and lesion size changes	The SUVs of 68Ga-DOTA-BPP in individual lesions will be compared to the changes in lesion sizes	1 year