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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Carcinoma; Receptor, ErbB-2
• Intervention / Treatment: Drug: 68GaNOTA-Anti-HER2 VHH1

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: UZ BRUSSEL; Phone Number: +3224776013; Email: nucgmail@uzbrussel.be

Study Locations

• Belgium
  • Brussels, Belgium, 1090
    • Recruiting
    • UZ Brussel
    • Contact: UZ BRUSSEL; Phone Number: +3224776013; Email: nucgmail@uzbrussel.be
    • Principal Investigator: Tony Lahoutte, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: Principal Investigator: Tony LAHOUTTE, MD, Universitair Ziekenhuis Brussel

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2017
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 24, 2017
• First Submitted That Met QC Criteria: October 31, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: HER2; Brain metastasis
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Neoplastic Processes; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasm Metastasis; Brain Neoplasms
• Other Study ID Numbers: UZBRU_VHH1_2; 2015-002328-24 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No