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

Primary Purpose

Breast Neoplasm, Breast Carcinoma, Receptor, ErbB-2

Status
Recruiting
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
68GaNOTA-Anti-HER2 VHH1
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Neoplasm focused on measuring Brain metastasis, HER2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Uz BrusselRecruiting

Outcomes

Primary Outcome Measures

The tumor targeting potential in brain metastasis
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.
The tumor targeting potential in brain metastasis
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

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

Full Information

First Posted
October 24, 2017
Last Updated
July 10, 2023
Sponsor
Universitair Ziekenhuis Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT03331601
Brief Title
Evaluation of 68-GaNOTA-Anti-HER2 VHH1 Uptake in Brain Metastasis of Breast Carcinoma Patients
Official Title
Evaluation of 68GaNOTA-Anti-HER2 VHH1 Uptake in Brain Metastasis of Breast Carcinoma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 16, 2017 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitair Ziekenhuis Brussel

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm, Breast Carcinoma, Receptor, ErbB-2
Keywords
Brain metastasis, HER2

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
68GaNOTA-Anti-HER2 VHH1
Intervention Description
Injection of the radiopharmaceutical and PET/CT 90 min post injection
Primary Outcome Measure Information:
Title
The tumor targeting potential in brain metastasis
Description
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.
Time Frame
90 min post injection
Title
The tumor targeting potential in brain metastasis
Description
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.
Time Frame
90 min post injection
Secondary Outcome Measure Information:
Title
Change in uptake in brain lesions evaluated by PET/CT scan during or after treatment
Description
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
Time Frame
up to 2 years after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
UZ Brussel
Phone
+3224776013
Email
nucgmail@uzbrussel.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marleen KEYAERTS, MD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uz Brussel
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
UZ BRUSSEL
Phone
+3224776013
Email
nucgmail@uzbrussel.be
First Name & Middle Initial & Last Name & Degree
Marleen Keyaerts, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26449837
Citation
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.
Results Reference
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Evaluation of 68-GaNOTA-Anti-HER2 VHH1 Uptake in Brain Metastasis of Breast Carcinoma Patients

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