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

NCT ID: NCT03924466

Last Updated: 2024-02-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2024-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

68GaNOTA-Anti-HER2 VHH1

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

HER2-PET/CT

Eligibility Criteria

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:

• 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

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 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.

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

COHORT 1 & 3:

• Patient who participated already in this study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kom Op Tegen Kanker

OTHER

Sponsor Role: collaborator

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

UNKNOWN

Sponsor Role: collaborator

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marleen KEYAERTS, MD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Locations

Uz Brussel

Brussels, Brussels Capital, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

UZ Brussel

Role: CONTACT

nugmail@uzbrussel.be

+3224776013

Facility Contacts

UZ BRUSSEL

Role: primary

nugmail@uzbrussel.be

3224776013

Other Identifiers

2016-002164-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

UZBRU_VHH1_3

Identifier Type: -

Identifier Source: org_study_id