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

This study is currently recruiting participants.
Verified May 2017 by Universitair Ziekenhuis Brussel
Sponsor:
ClinicalTrials.gov Identifier:
NCT03331601
First Posted: November 6, 2017
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Universitair Ziekenhuis Brussel
  Purpose
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.

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Universitair Ziekenhuis Brussel:

Primary Outcome Measures:
  • 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.

  • 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.


Estimated Enrollment: 30
Actual Study Start Date: February 24, 2017
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: 68GaNOTA-Anti-HER2 VHH1
    Injection of the radiopharmaceutical and PET/CT 90 min post injection
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have given informed consent
  • Female patients
  • 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:

  • Male patients
  • 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 who are unlikely to cooperate with the requirements of the study
  • Patients who are unwilling and/or unable to give informed consent
  • Patients at increased risk of death from a pre-existing concurrent illness
  • Patients who participated already in this study, or in a previous trial with VHH1.
  Contacts and Locations
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
Contact: UZ Brussel +3224776013 afspraak_nucleaire@uzbrussel.be

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

Publications:
Responsible Party: Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT03331601     History of Changes
Other Study ID Numbers: UZBRU_VHH1_2
2015-002328-24 ( EudraCT Number )
First Submitted: October 24, 2017
First Posted: November 6, 2017
Last Update Posted: November 6, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
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:
Brain metastasis
HER2

Additional relevant MeSH terms:
Carcinoma
Neoplasm Metastasis
Breast Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents