Phase 2 study to evaluate the uptake of 68GaNOTA-anti-HER2 VHH1, a new tracer for positron emissie tomografic imaging (PET/CT scan) of brain metastasis in cancer patients.

Evaluation of 68GaNOTA-Anti-HER2 VHH1 uptake in brain metastasis of cancer patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002328-24-BE

Enrollment

Registered

2015-07-09

Start date

2015-09-04

Completion date

Unknown

Last updated

2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

brain metastasis lesions from potential HER2 cancer patients

Interventions

Product Name: 68GaNOTA-Anti-HER2 VHH1 Product Code: 68GaNOTA-Anti-HER2 VHH1 Pharmaceutical Form: Solution for injection INN or Proposed INN: GALLIUM 68(68-GA) Other descriptive name: GALLIUM 68(68-G

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients who have given informed consent - Female patients - Age 18 years or older - Patients with brain metastasised 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: - Male patients - 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 who are unlikely to cooperate with the requirements of the study - Patients who are unwilling and/or unable to give informed consent - Patients at increased risk of death from a pre-existing concurrent illness - Patients who participated already in this study, or in a previous trial with VHH1.

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the uptake of 68GaNOTA-Anti-HER2 VHH1 in brain metastasis lesions from HER2-positive and HER2-negative patients.;Secondary Objective: Not applicable;Primary end point(s): The tumor targeting potential in brain metastasis ;Timepoint(s) of evaluation of this end point: end of trial	—

Secondary

Measure	Time frame
Secondary end point(s): The tumor targeting potential in other than brain metastasis ;Timepoint(s) of evaluation of this end point: end of trial	—

Countries

Belgium

Contacts

Public ContactTony Lahoutte

UZ Brussel

3224775020

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026