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

Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03331601
• Other study ID #: UZBRU_VHH1_2
• Secondary ID: 2015-002328-24
• Status: Recruiting
• Phase: Phase 2
• Start date: October 16, 2017
• Est. completion date: December 2026

Study information

• Verified date: February 2024
• Source: Universitair Ziekenhuis Brussel
• Contact: UZ Brussel
• Phone: +3224776013
• Email: nucgmail[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Carcinoma
• Neoplasm Metastasis
• Receptor, ErbB-2

Intervention

Drug:
• 68GaNOTA-Anti-HER2 VHH1
Injection of the radiopharmaceutical and PET/CT 90 min post injection

Locations

Country	Name	City	State
Belgium	Uz Brussel	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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