Repeatability Of 68-GaNOTA-Anti-HER2 VHH1 PET/CT In Breast Carcinoma Patients

Study Overview

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

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.

N/A

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

UZBRU_VHH1_3
2016-002164-13 (EUDRACT_NUMBER Identifier) (EUDRACT_NUMBER: )

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-04-18	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-02-15
First Submitted that Met QC Criteria 2019-04-18	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-02-16
First Posted (ACTUAL) 2019-04-23	Results First Posted N/A	Last Verified 2024-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
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-esophage	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, dep

Participant Group/Arm

Intervention/Treatment

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-esophage

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, dep

Primary Outcome Measures	Measure Description	Time Frame
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)

Secondary Outcome Measures	Measure Description	Time Frame
Within-patient tumor heterogeneity for HER2 expression using PET/CT imaging	Within-patient tumor heterogeneity for HER2 expression, observed on 68GaNOTA-Anti-HER2 VHH1 PET/CT or biopsy analyses	90 min post injection
Immunogenicity	Immunogenicity assessed on plasma samples obtained prior to injection of the IMP and obtained between 60 and 365 days after the (first) injection	prior to and between 60 and 365 days after the first injection
Histopathological results of biopsied lesions and correlation with PET/CT results	semi-quantitative score of HER2 expression using immunohistochemistry performed on biopsied/resected tissues if available	max 28 days after the second PET/CT
Influence image-guide biopsy on patient management	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	Within 3 months following the last intervention

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: UZ Brussel

Phone Number: +3224776013

Email: nugmail@uzbrussel.be

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

Patient who has given informed consent
Patient with age 18 years or older
Patients with locally advanced, unresectable, or metastatic cancer disease , with at least 1 lesion of at least 10 mm maximal diameter (For lymph node metastases, short axis at least 10 mm) of any of the following types:

breast carcinoma with low, intermediate or high HER2-expression, based on IHC 1+ or IHC 2+ or IHC 3+, as determined by local assessment on any of the available cancer tissues
salivary gland cancer
adenocarcinoma of the gastric body or gastro-esophageal junction
endometrial cancer
cancer of cervix uteri
Non-small cell lung cancer
biliary tract cancer including intra- or extrahepatic cholangiocarcinoma and tumors arising in the ampulla of Vater or gallbladder.
pancreatic cancer
colorectal cancer
urothelial carcinoma, including transitional cell or predominantly transitional cell carcinoma of the renal pelvis, ureter, urinary bladder or urethra.
prostate cancer
Other solid malignant tumors with intermediate or high HER2-expression, based on IHC 2+ or IHC 3+, as determined by local assessment on any of the available cancer tissues
Patients who have progressed following at least one prior systemic treatment for metastatic or advanced disease, or who have no satisfactory alternative treatment option, according to the treating physician (based on all available data such as medical imaging, lab results, clinical examination, …), and who are considered for a next line of systemic treatment. Patients who already participated in the trial and who are diagnosed with progressive or recurrent disease can be re-included if all inclusion criteria and none of the exclusion criteria apply.

Patient who has given informed consent
Patient with age 18 years or older
Patient with local or locally advanced HER2-positive (either IHC 3+ and/or ISH positive) breast carcinoma, who is planned for neo-adjuvant treatment prior to surgery, and who is suspected for axillary lymph node invasion, based on clinical assessment, ultrasound, CT or MRI, or who has a confirmed lymph node invasion
Patients who either had 18F-FDG- PET/CT in the last 4 weeks before inclusion, or for whom 18F-FDG- PET/CT is planned before start of neoadjuvant treatment.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Kom Op Tegen Kanker
Agentschap voor Innovatie door Wetenschap en Technologie, Project Toegepast Biomedisch onderzoek met een primair Maatschappelijke finaliteit.

Investigators

PRINCIPAL_INVESTIGATOR: Marleen KEYAERTS, MD, Universitair Ziekenhuis Brussel

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Caregivers

Clinical Trial Record