Evaluation of 68-GaNOTA-Anti-HER2 VHH1 Uptake in Brain Metastasis of Breast Carcinoma Patients
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ClinicalTrials.gov Identifier: NCT03331601 |
Recruitment Status :
Recruiting
First Posted : November 6, 2017
Last Update Posted : March 7, 2022
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Sponsor:
Universitair Ziekenhuis Brussel
Information provided by (Responsible Party):
Universitair Ziekenhuis Brussel
Tracking Information | |||||||
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First Submitted Date ICMJE | October 24, 2017 | ||||||
First Posted Date ICMJE | November 6, 2017 | ||||||
Last Update Posted Date | March 7, 2022 | ||||||
Actual Study Start Date ICMJE | October 16, 2017 | ||||||
Estimated Primary Completion Date | September 2023 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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
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Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Evaluation of 68-GaNOTA-Anti-HER2 VHH1 Uptake in Brain Metastasis of Breast Carcinoma Patients | ||||||
Official Title ICMJE | Evaluation of 68GaNOTA-Anti-HER2 VHH1 Uptake in Brain Metastasis of Breast Carcinoma Patients | ||||||
Brief Summary | 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. |
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Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Diagnostic |
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Condition ICMJE |
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Intervention ICMJE | Drug: 68GaNOTA-Anti-HER2 VHH1
Injection of the radiopharmaceutical and PET/CT 90 min post injection
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Study Arms ICMJE | Not Provided | ||||||
Publications * | Keyaerts M, Xavier C, Heemskerk J, Devoogdt N, Everaert H, Ackaert C, Vanhoeij M, Duhoux FP, Gevaert T, Simon P, Schallier D, Fontaine C, Vaneycken I, Vanhove C, De Greve J, Lamote J, Caveliers V, Lahoutte T. Phase I Study of 68Ga-HER2-Nanobody for PET/CT Assessment of HER2 Expression in Breast Carcinoma. J Nucl Med. 2016 Jan;57(1):27-33. doi: 10.2967/jnumed.115.162024. Epub 2015 Oct 8. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
30 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | December 2023 | ||||||
Estimated Primary Completion Date | September 2023 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Belgium | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03331601 | ||||||
Other Study ID Numbers ICMJE | UZBRU_VHH1_2 2015-002328-24 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Universitair Ziekenhuis Brussel | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Universitair Ziekenhuis Brussel | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Universitair Ziekenhuis Brussel | ||||||
Verification Date | December 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |