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

Sponsor

Universitair Ziekenhuis Brussel (Other)

Overall Status

Recruiting

CT.gov ID

NCT03331601

Collaborator

(none)

Enrollment

Location

73.5

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasm Breast Carcinoma Receptor, ErbB-2	Drug: 68GaNOTA-Anti-HER2 VHH1	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Oct 16, 2017

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Outcome Measures

Primary Outcome Measures

The tumor targeting potential in brain metastasis [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 [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.

Secondary Outcome Measures

Change in uptake in brain lesions evaluated by PET/CT scan during or after treatment [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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