Application of 68GA-labeled CD73 Targeting Probe PET/CT Imaging in the Diagnosis of Breast Cancer

May 8, 2024 updated by: Peking Union Medical College Hospital
We plan to conduct a 68Ga-DOTA-dPNE PET/CT imaging study on breast cancer patients to observe the binding of the tracer to lesions and evaluate CD73 expression. Alongside this, we will correlate these imaging results with relevant clinical indicators to assess the effectiveness of 68Ga-DOTA-dPNE in diagnosing and guiding treatment in breast cancer patients. This study aims to predict responses to targeted therapies.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Early Phase 1

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
      • Dongcheng, Beijing, China, 100730

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

Yes

Description

Inclusion Criteria:

  • 1: Age: ≥18 years old female, expected survival ≥12 weeks; 2: Without radiotherapy and chemotherapy, surgery or biopsy is feasible to obtain pathological diagnosis; 3: Standard Solid Tumor Response Evaluation Criteria (RECIST) version 1.1 with at least one measurable target lesion; 4: Obtain written informed consent and be able to follow up

Exclusion Criteria:

  • 1: Severe liver and kidney dysfunction; 2: Women who are planning to conceive, pregnant, or breastfeeding, as well as those planning to have children during the study period, are not eligible to participate in this research. Women of childbearing potential must use effective contraception throughout the course of the study; 3: Individuals unable to lie flat for thirty minutes; 4: Suffers from claustrophobia or other mental illnesses; 5: Researchers believe that the subject has other conditions that make them unsuitable for inclusion in this study; 6: Refuses to join this clinical study.

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 68GA-DOTA-dPNE
Each patient receive a single intravenous injection of 68GA-DOTA-dPNE 0.5-0.6 mci/kg and undergo PET/CT
Drug: 68GA-DOTA-dPNE
Patients with breast cancer receive intravenously 68GA-DOTA-dPNE followed by PET/CT after 40min of injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The evaluation of diagnostic performance of 68Ga-DOTA-dPNE PET in breast cancer
Time Frame: through study completion, an average of 1 year
Patients with histologically proven breast cancer will be prospectively recruited in this study. They will receive 68Ga-DOTA-dPNE and 18F-FDG. The detection rates of lesions, bones and lymph nodes (visual) were compared.
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Xianzhong ZHANG, Peking Union Medical College Hospital

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 (Estimated)

May 10, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

May 8, 2024

First Submitted That Met QC Criteria

May 8, 2024

First Posted (Actual)

May 13, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCH-NM-CD73

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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