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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002328-24 | EudraCT Number |
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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 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68GaNOTA-Anti-HER2 VHH1 | Drug | Injection of the radiopharmaceutical and PET/CT 90 min post injection |
| Measure | Description | Time Frame |
|---|---|---|
| The tumor targeting potential in brain metastasis | The tumor targeting potential in brain metastasis will be visually scored as positive or negative by an experienced nuclear medicine physician, unaware of the HER2-status. | 90 min post injection |
| The tumor targeting potential in brain metastasis | The tumor targeting potential in brain metastasis will be assessed quantitatively using Standard Uptake Values (SUV) by an experienced nuclear medicine physician, unaware of the HER2-status. | 90 min post injection |
| Measure | Description | Time Frame |
|---|---|---|
| Change in uptake in brain lesions evaluated by PET/CT scan during or after treatment | 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 | up to 2 years after inclusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tony Lahoutte, MD | Universitair Ziekenhuis Brussel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uz Brussel | Brussels | Brussels Capital | 1090 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26449837 | Background | 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. |
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| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D016543 | Central Nervous System Neoplasms |
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| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |