Evaluation of 68-GaNOTA-Anti-HER2 VHH1 Uptake in Brain Metastasis of Breast Carcinoma Patients
|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: NCT03331601|
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : February 15, 2021
This study investigates the uptake of the radiopharmaceutical 68-GaNOTA-Anti-HER2 VHH1 in brain metastasis using PET/CT imaging. Patients with HER2-positive and HER2-negative breast cancer will be included and the uptake in their lesions will be compared.
Optional 68-GaNOTA-Anti-HER2 VHH1 scans may be performed during or after treatment, at time points 12±6 weeks and 24±9 weeks after the first scan.
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasm Breast Carcinoma Receptor, ErbB-2||Drug: 68GaNOTA-Anti-HER2 VHH1||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Evaluation of 68GaNOTA-Anti-HER2 VHH1 Uptake in Brain Metastasis of Breast Carcinoma Patients|
|Actual Study Start Date :||February 24, 2017|
|Estimated Primary Completion Date :||September 2023|
|Estimated Study Completion Date :||December 2023|
- Drug: 68GaNOTA-Anti-HER2 VHH1
Injection of the radiopharmaceutical and PET/CT 90 min post injection
- The tumor targeting potential in brain metastasis [ Time Frame: 90 min post injection ]The tumor targeting potential in brain metastasis and other known breast carcinoma lesions will be visually scored as positive or negative by an experienced nuclear medicine physician, unaware of the HER2-status.
- The tumor targeting potential in brain metastasis [ Time Frame: 90 min post injection ]The tumor targeting potential in brain metastasis and other known breast carcinoma lesions will be assessed quantitatively using Standard Uptake Values (SUV) by an experienced nuclear medicine physician, unaware of the HER2-status.
- Change in uptake in brain lesions evaluated by PET/CT scan during or after treatment [ Time Frame: up to 2 years after inclusion ]If available, uptake will be evaluated during and after treatment and compared to baseline values. Results will be compared to information of patient's disease course
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): NCT03331601
|Contact: UZ Brusselemail@example.com|
|Brussels, Belgium, 1090|
|Contact: UZ BRUSSEL +3224776013 firstname.lastname@example.org|
|Principal Investigator: Marleen Keyaerts, MD|
|Principal Investigator:||Marleen KEYAERTS, MD||Universitair Ziekenhuis Brussel|