Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Digestive System Diseases

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Mouth and Tooth Diseases

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Prostatic Neoplasms

Neoplasm Metastasis

Stomach Neoplasms

Breast Neoplasms

Pancreatic Neoplasms

Cholangiocarcinoma

Carcinoma, Transitional Cell

Uterine Neoplasms

Endometrial Neoplasms

Biliary Tract Neoplasms

Salivary Gland Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urogenital Neoplasms

Genital Diseases

Urogenital Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Genital Neoplasms, Female

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Adenocarcinoma

Breast Diseases

Skin Diseases

Biliary Tract Diseases

Mouth Neoplasms

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Salivary Gland Diseases

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Stomach Cancer

Pancreatic Cancer

Bile Duct Cancer

Biliary Tract Cancer

Transitional Cell Carcinoma

Oral Cancer

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.

68GaNOTA-Anti-HER2 VHH1

UZ Brussel

UZ BRUSSEL

MARLEEN KEYAERTS, MD

Marleen KEYAERTS, MD

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.

The trial consists of 3 different patient cohorts that are each investigated using a new diagnostic imaging radiopharmaceutical

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

Quantification of 68-GaNOTA-Anti-HER2 VHH1 Uptake in Metastasis of Breast Carcinoma Patients and Assessment of Repeatability (VUBAR) - Pilot Study

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.

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).

Within-patient tumor heterogeneity for HER2 expression, observed on 68GaNOTA-Anti-HER2 VHH1 PET/CT or biopsy analyses

Immunogenicity assessed on plasma samples obtained prior to injection of the IMP and obtained between 60 and 365 days after the (first) injection

semi-quantitative score of HER2 expression using immunohistochemistry performed on biopsied/resected tissues if available

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

Kom Op Tegen Kanker

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

Universitair Ziekenhuis Brussel

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Repeatability of 68-GaNOTA-Anti-HER2 VHH1 PET/CT in Breast Carcinoma Patients	NCT03924466	Metastatic Brea... Locally Advance... Cancer of Pancr... Solid Tumor Wit... Salivary Gland ... Gastric Cancer Endometrial Can... Uterine Cancer Non Small Cell ... Biliary Tract C... Cholangiocarcin... Colorectal Canc... Urothelial Carc... Prostate Cancer	68GaNOTA-Anti-H...	18 Years -	Universitair Ziekenhuis Brussel
Repeatability of 68-GaNOTA-Anti-HER2 VHH1 PET/CT in Breast Carcinoma Patients	NCT03924466	Metastatic Brea... Locally Advance... Cancer of Pancr... Solid Tumor Wit... Salivary Gland ... Gastric Cancer Endometrial Can... Uterine Cancer Non Small Cell ... Biliary Tract C... Cholangiocarcin... Colorectal Canc... Urothelial Carc... Prostate Cancer	68GaNOTA-Anti-H...	18 Years -	Universitair Ziekenhuis Brussel

Spots Global Cancer Trial Database for solid tumor with intermediate or high her2 expression