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Trial Title:
PET Imaging of 68Ga-Her2-affibody in Tumors With High Her2 Expression
NCT ID:
NCT06289517
Condition:
Neoplasms
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
68Ga-Her2-affibody
PET/CT
Neoplasms
Study type:
Interventional
Study phase:
N/A
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-Her2-affibody
Description:
68Ga-Her2-affibody is injected intravenously with a dose of 0.06-0.08 mCi/kg.
Arm group label:
68Ga-Her2-affibody
Other name:
Her2 specific PET imaging
Summary:
This project uses HER2 protein as the target group of radiodrugs to explore the
diagnostic efficacy, safety and metabolic characteristics of 68Ga-Her2-affibody in the
expression status of HER2, aiming to provide a new imaging method for the determination
of HER2 status in breast cancer At the same time, it also provides new methods and means
for early diagnosis, accurate staging, recurrence judgment, treatment decision-making and
prognosis judgment of malignant tumors such as lung cancer, gastrointestinal cancer and
bladder cancer, and provides scientific basis for precise treatment of malignant tumors.
Detailed description:
This project uses HER2 protein as the target group of radiodrugs to explore the
diagnostic efficacy, safety and metabolic characteristics of 68Ga-Her2-affibody in the
expression status of HER2 in whole body cancer lesions, aiming to provide a new imaging
method for the determination of HER2 status in breast cancer and supplement more overall
information that is difficult to obtain by traditional core needle biopsy. At the same
time, it also provides new methods and means for early diagnosis, accurate staging,
recurrence judgment, treatment decision-making and prognosis judgment of malignant tumors
such as lung cancer, gastrointestinal cancer and bladder cancer, and provides scientific
basis for precise treatment of malignant tumors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- patients with confirmed or suspected cancer; Signed written informed consent
Exclusion Criteria:
-
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University First Hospital
Address:
City:
Beijing
Zip:
100034
Country:
China
Contact:
Last name:
Lei Yin, Dr.
Phone:
+861083575252
Email:
jack-yin@163.com
Start date:
April 1, 2024
Completion date:
June 30, 2025
Lead sponsor:
Agency:
Peking University First Hospital
Agency class:
Other
Source:
Peking University First Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06289517