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

Sponsor
Universitair Ziekenhuis Brussel (Other)
Overall Status
Recruiting
CT.gov ID
NCT03331601
Collaborator
(none)
30
1
73.5
0.4

Study Details

Study Description

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 breast 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: 68GaNOTA-Anti-HER2 VHH1
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Diagnostic
Official Title:
Evaluation of 68GaNOTA-Anti-HER2 VHH1 Uptake in Brain Metastasis of Breast Carcinoma Patients
Actual Study Start Date :
Oct 16, 2017
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Outcome Measures

Primary Outcome Measures

  1. The tumor targeting potential in brain metastasis [90 min post injection]

    The tumor targeting potential in brain metastasis and other known breast carcinoma lesions will be visually scored as positive or negative by an experienced nuclear medicine physician, unaware of the HER2-status.

  2. The tumor targeting potential in brain metastasis [90 min post injection]

    The tumor targeting potential in brain metastasis and other known breast carcinoma lesions will be assessed quantitatively using Standard Uptake Values (SUV) by an experienced nuclear medicine physician, unaware of the HER2-status.

Secondary Outcome Measures

  1. Change in uptake in brain lesions evaluated by PET/CT scan during or after treatment [up to 2 years after inclusion]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients who have given informed consent

  • Age 18 years or older

  • Patients with brain metastasized breast carcinoma, with at least 1 brain lesion of at least 8 mm maximal diameter, as measured by CT or MRI.

  • 20 patients with HER2-positive breast carcinoma and 10 with HER2-negative breast carcinoma will be included

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Uz Brussel Brussels Belgium 1090

Sponsors and Collaborators

  • Universitair Ziekenhuis Brussel

Investigators

  • Principal Investigator: Marleen KEYAERTS, MD, Universitair Ziekenhuis Brussel

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT03331601
Other Study ID Numbers:
  • UZBRU_VHH1_2
  • 2015-002328-24
First Posted:
Nov 6, 2017
Last Update Posted:
Mar 7, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Universitair Ziekenhuis Brussel
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 7, 2022