Evaluation of 68-GaNOTA-Anti-HER2 VHH1 Uptake in Brain Metastasis of Breast Carcinoma Patients

STATUS

Recruiting
End date

Dec 24, 2023
participants needed

30
sponsor

Universitair Ziekenhuis Brussel

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Updated on 25 February 2022

See if I qualify

cancer

carcinoma

breast cancer

metastasis

HER2

erbb2

breast carcinoma

her2/neu-negative breast cancer

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 126 weeks and 249 weeks after the first scan.

Details

Condition	Breast Neoplasm, Breast Carcinoma, Receptor, ErbB-2
Treatment	68GaNOTA-Anti-HER2 VHH1
Clinical Study Identifier	NCT03331601
Sponsor	Universitair Ziekenhuis Brussel
Last Modified on	25 February 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Patients who have given informed consent
	Age 18 years or older
	Patients with brain metastasized breast carcinoma, with at least 1 brain lesion of at least 8 mm maximal diameter, as measured by CT or MRI
	patients with HER2-positive breast carcinoma and 10 with HER2-negative breast carcinoma will be included
Exclusion Criteria
	Pregnant patients
	Breast feeding patients
	Patients with recent (< 1 week) gastrointestinal disorders with diarrhea as major symptom
	Patients with any serious active infection
	Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the test radiopharmaceutical
	Patients who cannot communicate reliably with the investigator
	Patients at increased risk of death from a pre-existing concurrent illness

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Evaluation of 68-GaNOTA-Anti-HER2 VHH1 Uptake in Brain Metastasis of Breast Carcinoma Patients