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Repeatability of 68-GaNOTA-Anti-HER2 VHH1 PET/CT in Breast Carcinoma Patients (VUBAR)

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. Identifier: NCT03924466
Recruitment Status : Recruiting
First Posted : April 23, 2019
Last Update Posted : October 23, 2020
Kom Op Tegen Kanker
Agentschap voor Innovatie door Wetenschap en Technologie, Project Toegepast Biomedisch onderzoek met een primair Maatschappelijke finaliteit.
Information provided by (Responsible Party):
Universitair Ziekenhuis Brussel

Brief Summary:
Study objective: To quantify the uptake of 68GaNOTA-Anti-HER2 VHH1 in local or distant metastases from breast carcinoma patients and to assess repeatability of the image-based HER2 quantification. The uptake will be correlated to results obtained via biopsy of the same lesion, if available. Time schedule: After inclusion, patients will be injected intravenously with 37 - 185 MBq 68GaNOTA-Anti-HER2 VHH1 with a total mass of up to 200 μg NOTA-Anti-HER2 VHH1. Serum and plasma samples will be collected at injection. At 90 min after injection, a total body PET/CT scan will be performed. Patients will undergo a second PET/CT procedure, identical to the first procedure, within 8 days, with a minimal interval of 18h. Based on PET/CT images, up to 2 lesions will be selected for optional image-guided biopsy. Biopsy will be performed max. 28 days after the second PET/CT. Plasma and serum samples will be obtained between 60 and 365 days after first injection.

Condition or disease Intervention/treatment Phase
Metastatic Breast Carcinoma Locally Advanced Breast Cancer Drug: 68GaNOTA-Anti-HER2 VHH1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Quantification of 68-GaNOTA-Anti-HER2 VHH1 Uptake in Metastasis of Breast Carcinoma Patients and Assessment of Repeatability (VUBAR) - Pilot Study
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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

Primary Outcome Measures :
  1. Repeatability of lesional PET/CT characteristics [ Time Frame: 90 min post injection ]
    The lesional tracer uptake in local and distant metastases of at least 12 mm (for lymph nodes short axis) will be measured on both PET/CT's (expressed as standard uptake value (SUV) and repeatability will be calculated.

Secondary Outcome Measures :
  1. Within-patient tumor heterogeneity for HER2 expression using PET/CT imaging [ Time Frame: 90 min post injection ]
    Within-patient tumor heterogeneity for HER2 expression, observed on 68GaNOTA-Anti-HER2 VHH1 PET/CT or biopsy analyses

  2. Immunogenicity [ Time Frame: prior to and between 60 and 365 days after the first injection ]
    Immunogenicity assessed on plasma samples obtained prior to injection of the IMP and obtained between 60 and 365 days after the (first) injection

  3. Histopathological results of biopsied lesions and correlation with PET/CT results [ Time Frame: max 28 days after the second PET/CT ]
    semi-quantitative score of HER2 expression using immunohistochemistry performed on biopsied/resected tissues if available

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patients will only be included in the study if they meet all of the following criteria:

  • Patient who has given informed consent
  • Patient with age 18 years or older
  • Patient with locally or distantly advanced breast carcinoma, with at least 1 lesion of at least 12 mm maximal diameter. For lymph node metastases, the largest diameter should be at least 15 mm and the short axis at least 12 mm.

Exclusion Criteria:

Patients will not be included in the study if one or more of the following criteria applies:

  • Patient is pregnant
  • Patient is breast feeding
  • Patient with recent (< 1 week) gastrointestinal disorders with diarrhea as major symptom
  • Patient with any serious active infection
  • Patient who has 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
  • Patient who cannot communicate reliably with the investigator
  • Patient who is unlikely to cooperate with the requirements of the study
  • Patient who is unwilling and/or unable to give informed consent
  • Patient at increased risk of death from a pre-existing concurrent illness
  • Patient who participated already in this study.

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 identifier (NCT number): NCT03924466

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Contact: UZ Brussel +3224776013

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Uz Brussel Recruiting
Brussels, Brussel, Belgium, 1090
Contact: UZ BRUSSEL    3224776013   
Principal Investigator: MARLEEN KEYAERTS, MD         
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Kom Op Tegen Kanker
Agentschap voor Innovatie door Wetenschap en Technologie, Project Toegepast Biomedisch onderzoek met een primair Maatschappelijke finaliteit.
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Principal Investigator: Marleen KEYAERTS, MD Universitair Ziekenhuis Brussel
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Responsible Party: Universitair Ziekenhuis Brussel Identifier: NCT03924466    
Other Study ID Numbers: UZBRU_VHH1_3
2016-002164-13 ( EudraCT Number )
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: June 2020
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
Keywords provided by Universitair Ziekenhuis Brussel:
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Breast Diseases
Skin Diseases