Loading clinical trials...

Repeatability of 68-GaNOTA-Anti-HER2 VHH1 PET/CT in Breast Carcinoma Patients | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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

NCT03924466•Universitair Ziekenhuis Brussel

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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:
+18 more criteria

Exclusion Criteria

•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
+2 more criteria

Locations (1)

Uz Brussel

Brussels, Brussels Capital, Belgium

Key Dates

Start Date

April 1, 2019

Primary Completion Date

November 1, 2024

Completion Date

December 1, 2024

Last Updated

February 16, 2024

Enrollment

ESTIMATED participants

Conditions

Metastatic Breast CarcinomaLocally Advanced Breast CancerCancer of PancreasSolid Tumor With Intermediate or High HER2 ExpressionSalivary Gland CancerGastric CancerEndometrial CancerUterine CancerNon Small Cell Lung CancerBiliary Tract CancerCholangiocarcinomaColorectal CancerUrothelial CarcinomaProstate Cancer

Interventions

68GaNOTA-Anti-HER2 VHH1

DRUG

Contacts

UZ Brussel

CONTACT

+3224776013 nugmail@uzbrussel.be

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

NCT04704661

Advanced Breast CarcinomaAdvanced Colon Carcinoma+38 more

View study

RECRUITINGPHASE1

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

NCT05372640

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+6 more

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 16, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

A Study Comparing Cancer Imaging Approaches in People With Lobular Breast Cancer

A Study to Assess CLBR001+ABBV-461 in Subjects With Locally Advanced or Metastatic Breast Cancer

A Phase I/II Study of FWD1802 in Patients With ER+/HER2- Advanced BC.