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

Study Overview
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Brief Summary
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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 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.

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

Conditions
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Breast Neoplasm, Breast Carcinoma, Receptor, ErbB-2

Intervention / Treatment
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* Drug: 68GaNOTA-Anti-HER2 VHH1


Participation Criteria
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Eligibility Criteria
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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. 20 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 68GaNOTA-Anti-HER2 VHH1|Injection of the radiopharmaceutical and PET/CT 90 min post injection|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The tumor targeting potential in brain metastasis | 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. | 90 min post injection | 
| The tumor targeting potential in brain metastasis | 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. | 90 min post injection | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain metastasis, HER2