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History of Changes for Study: NCT03331601
Evaluation of 68-GaNOTA-Anti-HER2 VHH1 Uptake in Brain Metastasis of Breast Carcinoma Patients
Latest version (submitted March 4, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 31, 2017 None (earliest Version on record)
2 June 19, 2018 Study Status and Eligibility
3 March 11, 2019 Eligibility and Study Status
4 November 5, 2019 Study Status
5 February 10, 2021 Study Status, Outcome Measures and Study Description
6 December 17, 2021 Study Status and Contacts/Locations
7 March 4, 2022 Study Status
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Study NCT03331601
Submitted Date:  October 31, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: UZBRU_VHH1_2
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
Secondary IDs: 2015-002328-24 [EudraCT Number]
Open or close this module Study Status
Record Verification: May 2017
Overall Status: Recruiting
Study Start: February 24, 2017
Primary Completion: September 2019 [Anticipated]
Study Completion: December 2019 [Anticipated]
First Submitted: October 24, 2017
First Submitted that
Met QC Criteria:
October 31, 2017
First Posted: November 6, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
October 31, 2017
Last Update Posted: November 6, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Universitair Ziekenhuis Brussel
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: Breast Neoplasm
Breast Carcinoma
Receptor, ErbB-2
Keywords: Brain metastasis
HER2
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Diagnostic
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms:
Masking: Single (Outcomes Assessor)
Allocation: N/A
Enrollment: 30 [Anticipated]
Open or close this module Arms and Interventions
Intervention Details:
Drug: 68GaNOTA-Anti-HER2 VHH1
Injection of the radiopharmaceutical and PET/CT 90 min post injection
Open or close this module Outcome Measures
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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: Female
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: UZ Brussel
Telephone: +3224776013
Email: afspraak_nucleaire@uzbrussel.be
Study Officials: Marleen KEYAERTS, MD
Principal Investigator
Universitair Ziekenhuis Brussel
Locations: Belgium
Uz Brussel
[Recruiting]
Brussels, Belgium, 1090
Contact:Contact: UZ BRUSSEL +3224776013 afspraak_nucleaire@uzbrussel.be
Contact:Principal Investigator: Marleen Keyaerts, MD
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations: 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. PubMed 26449837
Links:
Available IPD/Information:

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