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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

Tracking Information
First Submitted Date  ICMJE October 24, 2017
First Posted Date  ICMJE November 6, 2017
Last Update Posted Date March 7, 2022
Actual Study Start Date  ICMJE October 16, 2017
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2017)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2021)
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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of 68-GaNOTA-Anti-HER2 VHH1 Uptake in Brain Metastasis of Breast Carcinoma Patients
Official Title  ICMJE Evaluation of 68GaNOTA-Anti-HER2 VHH1 Uptake in Brain Metastasis of Breast Carcinoma Patients
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Breast Neoplasm
  • Breast Carcinoma
  • Receptor, ErbB-2
Intervention  ICMJE Drug: 68GaNOTA-Anti-HER2 VHH1
Injection of the radiopharmaceutical and PET/CT 90 min post injection
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 31, 2017)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: UZ Brussel +3224776013 nucgmail@uzbrussel.be
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03331601
Other Study ID Numbers  ICMJE UZBRU_VHH1_2
2015-002328-24 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Universitair Ziekenhuis Brussel
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Universitair Ziekenhuis Brussel
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marleen KEYAERTS, MD Universitair Ziekenhuis Brussel
PRS Account Universitair Ziekenhuis Brussel
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP