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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-16

Study Completion Date

2026-12-31

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 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

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Conditions

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Carcinoma Receptor, ErbB-2

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Interventions

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68GaNOTA-Anti-HER2 VHH1

Injection of the radiopharmaceutical and PET/CT 90 min post injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who have given informed consent
* Age 18 years or older
* Patients with brain metastasized cancer, with at least 1 brain lesion of at least 8 mm maximal diameter, as measured by CT or MRI.
* Patients with potentially HER2-positive cancer. Either a HER2 staining should have been done in standard of care, or sufficient tissue should be available for HER2-staining for study purpose.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No