Research for the Molecular Imaging of the HER2 Targeting Tracer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04547309|
Recruitment Status : Recruiting
First Posted : September 14, 2020
Last Update Posted : September 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|HER2 Positive or Suspicious Positive Tumors||Radiation: 68Ga/18F-HER2 Affibody PET/CT scan||Not Applicable|
HER2 is an important biomarker and directly inﬂuences the treatment effect. The guidelines indicate that only HER2-positive patients are eligible for trastuzumab therapy.HER2 positivity is defined as a HER2 score of 3+ by IHC or FISH. However, gastroscopic biopsies are spatiotemporally limited because of the highly heterogeneous expression of HER2. And this procedure is invasive and may substantially increase the incidence of side effects. Additionally, patients with false-negative HER2 results miss the chance for targeted therapy. Moreover, HER2 status can change during the disease process.Thus, a noninvasive, whole-body, HER2-targeted imaging method may be valuable for choosing patients suitable for anti-HER2 therapy and monitoring the therapeutic efficacy. Direct labeling of HER2 antibodies with radionuclides allows clinicians to monitor HER2-targeted therapy and assists in patient staging. With the feasibility of a long half-life and decay time, positron emission tomography (PET) nuclides, such as 64Cu (T1/2= 12.7 h) and 89Zr (T1/2= 78.4 h), can label trastuzumab for the clinical PET imaging of HER2 in GC and breast cancer. Because of the long half-life of 89Zr, 89Zr-trastuzumab is estimated to produce a dosimetry exposure of 0.5 mSv/MBq (compared with the 0.019 mSv/MBq of 18FDG) in patients. Additionally, imaging needs to be performed several days after injection due to the slow blood clearance of antibodies.
In this study, 68Ga-HER2 Affibody or 18F-HER2 Affibody PET/CT imaging will be performed in patients with HER2-positive tumors to access the potential of 68Ga-HER2 Affibody or 18F-HER2 Affibody PET/CT to screen patients who can benefit from HER2 target treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Research for the Molecular Imaging of the HER2 Targeting Tracer|
|Actual Study Start Date :||September 7, 2020|
|Estimated Primary Completion Date :||August 30, 2023|
|Estimated Study Completion Date :||August 30, 2023|
|Experimental: 68Ga/18F-HER2 Affibody PET/CT scan||
Radiation: 68Ga/18F-HER2 Affibody PET/CT scan
HER2 Affibody, labeled with PET radio-nuclide ( 68Ga or F-18) will be used as a molecular imaging tracer for PET/CT scan. All participants will undergo 68Ga/18F-HER2 Affibody PET/CT scan.
- SUV [ Time Frame: 3 years ]The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value (SUV) on PET/CT
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04547309
|Beijing, Beijing, China, 100142|
|Contact: Shunlian Zhou 010-88196391 firstname.lastname@example.org|