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68Ga PET/CT Imaging in Breast Cancer Patients

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05622227
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
25.5
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

PSMA is highly expressed on the cell surface of the microvasculature of several solid tumors, including breast cancer. This makes it a potentially imaging target for the detection and grading of breast cancer. This pilot study was designed to evaluate the diagnostic performance of 68Ga-P16-093, a novel radiopharmaceutical targeting PSMA, which was compared with 18F-FDG in the same group of breast cancer patients.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Drug: 68Ga-P16-093
 Phase 1/Phase 2

Detailed Description

PSMA has been confirmed to be over expressed in vascular endothelial cells of various malignant solid tumors, such as breast cancer and renal cancer, which can provide growth advantages for various cancers by cutting the signal molecules involved in angiogenesis. Positron emission tomography (PET) imaging using radiolabeled molecules targeting PSMA can detect a variety of non prostate cancer solid tumors such as breast cancer and glioma. According to previous studies, PSMA can detect primary and metastasis lesions of breast cancer patients, and has a higher uptake value in triple negative breast cancer and HER2 overexpressed patients. The uptake may be related to tumor grade.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
68Ga-P16-093 PET/CT Imaging in Primary and Recurrent Breast Cancer Patients
Anticipated Study Start Date :
Nov 15, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 68Ga-P16-093 and 18F-FDG scan

Within 1 week, each patient underwent 68Ga-P16-093 and 18F-FDG PET/CT scan after intravenous administration of 68Ga-P16-093 and 18F-FDG, respectively.

Diagnostic Test: Drug: 68Ga-P16-093
Intravenous injection of 68Ga-P16-093 with the dosage of 1.5-1.8 MBq (0.04-0.05 mCi)/kg. Tracer doses of 68Ga-P16-093 will be used to image lesions of breast cancer by PET/CT.

Outcome Measures

Primary Outcome Measures

  1. Diagnostic performance [through study completion, an average of 1 year]

    comparing the number of tumor detected by 68Ga-P16-093 and 18F-FDG

Secondary Outcome Measures

  1. standardized uptake value (SUV) of tumor [through study completion, an average of 1 year]

    comparing the SUVmax of tumor of different lesions derived from 68Ga-P16-093 AND 18F-FDG

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • breast cancer patients highly suggested by ultrasound or histologically confirmed;

  • 68Ga-P16-093 PET/CT and 18F-FDG within two weeks;

  • signed written consent.

Exclusion Criteria:

  • known allergy against PSMA;

  • any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking Union Medical College Hospital Beijing China 100730

Sponsors and Collaborators

  • Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Zhaohui Zhu, Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT05622227
Other Study ID Numbers:
  • PekingUMCH-BCa093
First Posted:
Nov 18, 2022
Last Update Posted:
Nov 18, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Nov 18, 2022