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Trial Title:
Application of 68GA-labeled CD73 Targeting Probe PET/CT Imaging in the Diagnosis of Breast Cancer
NCT ID:
NCT06411678
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
68GA-DOTA-dPNE
Description:
Patients with breast cancer receive intravenously 68GA-DOTA-dPNE followed by PET/CT after
40min of injection
Arm group label:
68GA-DOTA-dPNE
Summary:
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
PUMCH
Address:
City:
Dongcheng
Zip:
100730
Country:
China
Contact:
Last name:
Chenhao JIA
Phone:
18548703382
Email:
jiachenhao24@163.com
Start date:
May 10, 2024
Completion date:
June 1, 2026
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06411678
