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

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ClinicalTrials.gov Identifier: NCT03331601
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : March 7, 2022
Sponsor:
Information provided by (Responsible Party):
Universitair Ziekenhuis Brussel

Study Description
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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
Breast Neoplasm Breast Carcinoma Receptor, ErbB-2 Drug: 68GaNOTA-Anti-HER2 VHH1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 16, 2017
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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

Outcome Measures
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Primary Outcome Measures :
  1. The tumor targeting potential in brain metastasis [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331601


Contacts
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Contact: UZ Brussel +3224776013 nucgmail@uzbrussel.be

Locations
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Belgium
Uz Brussel Recruiting
Brussels, Belgium, 1090
Contact: UZ BRUSSEL    +3224776013    nucgmail@uzbrussel.be   
Principal Investigator: Marleen Keyaerts, MD         
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
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Principal Investigator: Marleen KEYAERTS, MD Universitair Ziekenhuis Brussel
More Information
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Publications:

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Responsible Party: Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT03331601    
Other Study ID Numbers: UZBRU_VHH1_2
2015-002328-24 ( EudraCT Number )
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: March 7, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Brain metastasis
HER2
Additional relevant MeSH terms:
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Carcinoma
Neoplasm Metastasis
Brain Neoplasms
Breast Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplastic Processes
Pathologic Processes
 Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Breast Diseases
Skin Diseases