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

NCT03331601 | Terminated Phase 2

• 2 other identifiers: UZBRU_VHH1_22015-002328-24
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Carcinoma; Receptor, ErbB-2

Keywords

Brain metastasis; HER2

Outcome Measures

Primary Outcomes (2)

• The tumor targeting potential in brain metastasis

  The tumor targeting potential in brain metastasis 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 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 Outcomes (1)

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

  up to 2 years after inclusion

Interventions

68GaNOTA-Anti-HER2 VHH1 DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Uz Brussel

Brussels, Brussels Capital, 1090, Belgium

Location

Related Publications (1)

• Keyaerts M, Xavier C, Heemskerk J, Devoogdt N, Everaert H, Ackaert C, Vanhoeij M, Duhoux FP, Gevaert T, Simon P, Schallier D, Fontaine C, Vaneycken I, Vanhove C, De Greve J, Lamote J, Caveliers V, Lahoutte T. Phase I Study of 68Ga-HER2-Nanobody for PET/CT Assessment of HER2 Expression in Breast Carcinoma. J Nucl Med. 2016 Jan;57(1):27-33. doi: 10.2967/jnumed.115.162024. Epub 2015 Oct 8.

  PMID: 26449837 BACKGROUND

MeSH Terms

Conditions

Carcinoma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Tony Lahoutte, MD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: November 6, 2017
• Study Start: October 16, 2017
• Primary Completion: October 14, 2025
• Study Completion: October 14, 2025
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)