Repeatability of 68-GaNOTA-Anti-HER2 VHH1 PET/CT in Breast Carcinoma Patients (VUBAR)
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|ClinicalTrials.gov Identifier: NCT03924466|
Recruitment Status : Recruiting
First Posted : April 23, 2019
Last Update Posted : December 20, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Carcinoma Locally Advanced Breast Cancer Cancer of Pancreas Solid Tumor With Intermediate or High HER2 Expression Salivary Gland Cancer Gastric Cancer Endometrial Cancer Uterine Cancer Non Small Cell Lung Cancer Biliary Tract Cancer Cholangiocarcinoma Colorectal Cancer Urothelial Carcinoma Prostate Cancer||Drug: 68GaNOTA-Anti-HER2 VHH1||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||The trial consists of 3 different patient cohorts that are each investigated using a new diagnostic imaging radiopharmaceutical|
|Masking:||None (Open Label)|
|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 2024|
|Estimated Study Completion Date :||December 2024|
Experimental: Cancer patients
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.
Drug: 68GaNOTA-Anti-HER2 VHH1
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.
Other Name: HER2-PET/CT
- 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.
- Tracer update of 68GaNOTA-Anti-HER2 VHH1 in different cancer types [ Time Frame: 90 min post injection ]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).
- Feasibility and added value of 68GaNOTA-Anti-HER2 in neoadjuvant setting of breast carcinoma [ Time Frame: time of surgery following neo-adjuvant treatment (typically within 14 days following the second intervention) ]
- 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
- 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
- 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
- Influence image-guide biopsy on patient management [ Time Frame: Within 3 months following the last intervention ]To determine in which relative number of patients, the patient management was altered after 68GaNOTA-Anti-HER2 VHH1 PET/CT and the subsequent optional biopsy
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): NCT03924466
|Contact: UZ Brusselemail@example.com|
|Brussels, Brussel, Belgium, 1090|
|Contact: UZ BRUSSEL 3224776013 firstname.lastname@example.org|
|Principal Investigator: MARLEEN KEYAERTS, MD|
|Principal Investigator:||Marleen KEYAERTS, MD||Universitair Ziekenhuis Brussel|