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NCT Number: NCT06203119

Construction and Clinical Translation of ACE Targeted Nuclear Medicine Imaging Probe

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ethics Committee of Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location status: Recruiting

Location contact

Shunlian Zhou

CONTACT

[email protected]

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. The biosafety, tolerability, and normal biodistribution characteristics of the 68Ga-DOTA-BPP tracer in patients with TNBC

    Time frame: 1 year

Secondary outcomes

  1. The detection rate of 68Ga-DOTA-BPP PET/CT for target lesions in TNBC, and its concordance with the results of 18F-FDG PET/CT and immunohistochemistry (IHC).

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Hua Zhu, M.D

CONTACT

[email protected]

13671224863

Qian Zhang

CONTACT

[email protected]

13765839835

Sponsors and collaborators

Lead sponsor

Peking University Cancer Hospital & Institute

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 12, 2024
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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