Construction and Clinical Translation of ACE Targeted Nuclear Medicine Imaging Probe

NCT ID: NCT06203119

Last Updated: 2024-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-01

Study Completion Date

2024-10-31

Brief Summary

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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

Detailed Description

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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

Conditions

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Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Cancer Hospital & Institute

OTHER

Sponsor Role lead

Responsible Party

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Hua Zhu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ethics Committee of Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qian Zhang

Role: CONTACT

13765839835

Hua Zhu, M.D

Role: CONTACT

13671224863

Facility Contacts

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Shunlian Zhou

Role: primary

Other Identifiers

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2023KT160

Identifier Type: -

Identifier Source: org_study_id

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