Advanced metastatic cancer of the colon or rectum MedDRA version: 20.0 Level: PT Classification code 10009956 Term: Colon cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10055114 Term: Colon cancer metastatic System Org
Conditions
Interventions
Product Name: IASON RGD 20 MBq/mL, solution for injection
Pharmaceutical Form: Solution for injection
INN or Proposed INN: gallium (68Ga) NODAGA-RGD
Oth
Sponsors
Lekárska fakulta Univerzity Komenského v Bratislave
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, all individual must meet all of the following criteria: 1. Male or female over 18 years of age with histologicaly confirmed metastatic cancer of the colon or rectum fulfilling the following criteria : a) Scheduled for treatment including antiangiogenic agent b) At least one measurable lesions according to RECIST 1.1 criteria (>10mm in long axis for non-lymph node lesions and >15mm in short axis for lymph node lesions). c) Availability of following examination data in DICOM III format performed less than 31 days prior inclusion: - Diagnostic CT of thorax, abdomen and pelvis - Fludeoxyglucose (18F) PET/CT 2. Capable of staying still in lying position for the duration of the PET/CT acquisition which can last up to 30 min in all, a "whole body" acquisition 3. ECOG performance status = 2 at inclusion 4. Patient with a life expectancy = 24 weeks from baseline 5. For women of childbearing age, the possibility of pregnancy should be ruled out at inclusion 6. Volunteer and able to follow the instructions necessary for the study 7. Having signed an informed consent to participate in the study 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 26
Exclusion criteria
Exclusion criteria: An individual who meets any of the following criteria will be excluded from participation in this study: - Pregnancy or lactation - Known allergy to components of the study product - Treatment scheduled does not include antiangiogenic agent - Life expectancy less than 6 months - ECOG Performance Status >2 or Karnofsky Performance Status <50%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 6 months after gallium (68Ga) NODAGA-FGD and at least two cycles of treatment including antiangiogenic agent.; Secondary Objective: 1. To validate and improve the interpretation criteria for gallium (68Ga) NODAGA-RGD PET/CT 2. To check the perfect tolerability of gallium (68Ga) NODAGA-RGD ;Primary end point(s): 1. Assessment of value of gallium (68Ga) NODAGA-RGD PET/CT to predict the response to treatment including antiangiogenic agent;Main Objective: 1. To compare the response rate to treatment including antiangiogenic agent in patients with advanced metastatic cancer of the colon or rectum , according to whether or not all known lesions, were visually positive on gallium (68Ga) NODAGA-RGD PET/CT before starting treatment including antiangiogenic agent | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Refinement of criteria for interpretation of gallium (68Ga) NODAGA-RGD PET/CT 2. Confirmation of perfect tolerability of gallium (68Ga) NODAGA-RGD ; Timepoint(s) of evaluation of this end point: 1. 6 months after gallium (68Ga) NODAGA-RGD and at least two cycles of treatment including antiangiogenic agent. 2. During, immediately after and up to 24 after administration of gallium (68Ga) NODAGA-RGD | — |
Countries
Slovakia
Contacts
Public ContactDepartment of Nuclear Medicine
Faculty of Medicine in Bratislava of Comenius University in Bratislava
Outcome results
None listed