Phase 2 Pilot study to evaluate the uptake of 68GaNOTA-anti-HER2 VHH1, a new tracer for positron emission tomografic imaging (PET/CT scan) of metastasis in cancer patients.
- Conditions
- Breast cancersalivary gland canceradenocarcinoma of the gastric body or gastro-esophageal junctionendometrial cancercancer of cervix uteriNon-small cell lung cancerbiliary tract cancerpancreatic cancercolorectal cancerurothelial carcinoma
- Registration Number
- EUCTR2016-002164-13-BE
- Lead Sponsor
- Z Brussel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 55
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
- Patient 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 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
-Patient who has progressed on or relapsed after a prior treatment regimen, according to the treating physician (based on all available data such as medical imaging, lab results, clinical examination, …), and who is considered for a next line of 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.
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
All cohorts:
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
-Patient who participated already in this study. (cohort 1 and 3)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method