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

NCT03924466 | Recruiting Phase 2

• 2 other identifiers: UZBRU_VHH1_32016-002164-13
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

HER2

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

Study Arms (1)

Cancer patients

EXPERIMENTAL

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

Interventions

68GaNOTA-Anti-HER2 VHH1 DRUG

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.

Also known as: HER2-PET/CT

Cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COHORT 1:
• 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.
• COHORT 2:
• 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
• 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

You may not qualify if:

• COHORT 3:
• 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 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 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• Kom Op Tegen Kanker: collaborator
• Agentschap voor Innovatie door Wetenschap en Technologie, Project Toegepast Biomedisch onderzoek met een primair Maatschappelijke finaliteit.: collaborator

Study Sites (1)

Uz Brussel

Brussels, Brussels Capital, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Pancreatic Neoplasms; Salivary Gland Neoplasms; Stomach Neoplasms; Endometrial Neoplasms; Uterine Neoplasms; Carcinoma, Non-Small-Cell Lung; Biliary Tract Neoplasms; Cholangiocarcinoma; Colorectal Neoplasms; Carcinoma, Transitional Cell; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Mouth Neoplasms; Head and Neck Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Biliary Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Marleen KEYAERTS, MD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

UZ Brussel

CONTACT

+3224776013; nugmail@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: April 23, 2019
• Study Start: April 1, 2019
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)