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VUBAR
Quantification of 68-GaNOTA-Anti-HER2 VHH1 Uptake in Metastasis of Breast Carcinoma Patients and Assessment of Repeatability (VUBAR) - Pilot Study
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
NIH
interventional
55
1 country
1
Study Start
April 1, 2019
Actual (reported)Primary Completion
November 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study objective: Cohort 1: 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. Cohort 2: To report on uptake of 68GaNOTA-Anti-HER2 VHH1 in different cancer types that might overexpress HER2 Cohort 3: To explore the feasibility and added value of 68GaNOTA-Anti-HER2 VHH1 in the neoadjuvant setting of HER2-expressing breast carcinoma 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 in cohort 1 will undergo a second PET/CT procedure, identical to the first procedure, within 8 days, with a minimal interval of 18h and maximal interval of 8 days. Patients in cohort 2 can undergo an optional 18F-FDG-PET/CT within 21 days prior to or after 68GaNOTA-Anti-HER2 VHH1. In cohort 1 and 2, 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 last PET/CT. Plasma and serum samples will be obtained between 60 and 365 days after first injection for patients in cohort 1 and between 42 and 365 days after first injection for patients in cohort 2. Patients in cohort 3 will undergo 68GaNOTA-Anti-HER2 VHH1 PET/CT prior to the start of neoadjuvant treatment and again after the last cycle of neoadjuvant treatment but prior to surgery. Plasma and serum samples will be obtained before each injection and between 42 and 365 days after the last injection.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 1, 2019
Actual (reported)April 18, 2019
Actual (reported)April 23, 2019
Actual (reported)November 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Repeatability of lesional PET/CT characteristics
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.
90 min post injection
Tracer update of 68GaNOTA-Anti-HER2 VHH1 in different cancer types
The lesional tracer uptake in different cancer types of at least 10 mm maximal diameter (for lymph nodes short axis) will be measured on PET/CT (expressed as standard uptake value (SUV).
90 min post injection
Feasibility and added value of 68GaNOTA-Anti-HER2 in neoadjuvant setting of breast carcinoma
time of surgery following neo-adjuvant treatment (typically within 14 days following the second intervention)
Cohort 1: locally advanced or metastatic breast cancer patients Cohort 2: Patients with locally advanced, unresectable, or metastatic cancer disease of breast with low, intermediate or high HER2-expression, salivary gland; gastric body or gastro-esophageal junction; endometrium; uterus; lung; biliary tract; gallbladder; pacreas; colorectum; urothelium; prostate; other solid with intermediate or high HER2-expression Cohort 3: Patients with local or locally advanced HER2-+ breast carcinoma, who are planned for neo-adjuvant treatment prior to surgery, and who are suspected for axillary lymph node invasion.
All subjects will receive at least one single intravenous injection of the IMP followed by a total body PET/CT prior to receiving standard-of-care therapy. A second injection of the IMP can be administered before or during standard-of-care treatment, depending on cohort.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Uz Brussel
Brussels, Brussels Capital, 1090, Belgium
Marleen KEYAERTS, MD
Universitair Ziekenhuis Brussel
First Submitted
April 18, 2019
First Posted
April 23, 2019
Study Start
April 1, 2019
Actual (reported)Primary Completion
Within-patient tumor heterogeneity for HER2 expression using PET/CT imaging
90 min post injection
Immunogenicity
prior to and between 60 and 365 days after the first injection
Histopathological results of biopsied lesions and correlation with PET/CT results
max 28 days after the second PET/CT
Influence image-guide biopsy on patient management
Within 3 months following the last intervention
Contact the study team to confirm eligibility.
November 2024
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 16, 2024
Record last verified: 2024-02
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Source: ClinicalTrials.gov.
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