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Optimalisatie van de behandeling met cetuximab voor patienten met uitgezaaide dikkedarm kanker door de opname van 89-zirconium gelabeld cetuximab te beoordelen middels PET-scan

ABSTRACT: Interventions: 89Zr-cetuximab PET scan: After a therapeutic dose of cetuximab, 10mg of 89Zr-cetuximab is injected. Six days after injection a PET-scan will be made. If this scan is considerd positive, meaning uptake in extra-hepatic metastases is present, the normal dose of cetuximab will be continued. If the first PET-scan is negative, we will increase the dose of cetuximab (3 by 3 cohort design) and repeat the PET-scan. The patient will continue the higher dose biweekly. Furthermore we will preform a 18F-FDG PET scan and 15O-H2O PET scan, on baseline and after 2 weeks of treatment, to evaluate early changes in respectively metabolic changes and changes in tumor perfusion. At baseline and after 3-4 week of treatment a skin biopsy and tumor biopsy will be done. We will preform oncogenic mutation analysis, we will determine EGFR expression and saturation. Primary outcome(s): 89Zr-cetuximab uptake in non-hepatic metastases (corrected VOIs) and the correlation with clinical benefit rate. 89Zr-cetuximab uptake in non-hepatic metastases with increased dosing of cetuximab (corrected VOIs). The clinical benefit rate (CR, PR and SD) based upon 89Zr-cetuximab image adjusted dosing Study Design: Non-randomized controlled trial, Open (masking not used), N/A , unknown, Parallel

DISEASE(S): Metastatic Colorecal Adenocarcinoma, K-ras And N-ras Wild Type

PROVIDER: 18849 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Optimalisatie van de behandeling van uitgezaaide darmkanker met cetuximab middels opname metingen van 89Zr gelabeld cetuximab mbv PET.

Project description:Interventions: Patients will be treated with cetuximab. For pharmacodynamic purposes PET-imaging with 89Zr-labelled cetuximab will be performed. In addition, two [18F-]-FDG PET-CT will be performed to explore early response. Patients will undergo blood sampling and two skin biopsies for pharmacodynamic purposes of 89Zr-labelled cetuximab and kinase activity profiles, respectively. Primary outcome(s): To demonstrate uptake of 89Zr-cetuximab in non-hepatic tumor lesions using immuno-PET when administered during the loading dose of cetuximab. Part two - Primary objective: To investigate whether there is an association between uptake of cetuximab in non-hepatic tumor lesions and response according to RECIST 1.1 criteria. Study Design: N/A: single arm study, Open (masking not used), N/A , unknown, Parallel

| 17685 | ecrin-mdr-crc

Treatment optimization of cetuximab in patients with metastatic colorectal cancer based on tumour uptake of 89Zr-labeled cetuximab assessed by PET

Project description:Primary objectives: The main objective of the first part of the study is the demonstration of 89Zr-cetuximab uptake in non-hepatic tumour lesions. The main objective of the second part is the association between 89Zr-cetuximab uptake in non-hepatic tumour lesions and treatment outcome. Primary endpoints: Part one - Primary endpointThe detection of 89Zr-cetuximab uptake in non-hepatic tumour lesions (present/absent; present being defined as levels measured in ROI’s > standard deviation of background +1). Part two – primary endpointThe % uptake (of total injected) 89Zr-cetuximab in non-hepatic tumour lesions as measured in ROI’s corrected for background levels. Part two - secondary endpoints1) The % uptake (of total injected) 89Zr-cetuximab in liver lesions as measured in ROI’s corrected for background levels.2) [18F-]FDG PET measurements (SUVmax) before and after 4 weeks of treatment with cetuximab.3) Grade of skin toxicity as measured by predefined criteria (see below). Other study parameters4) Serum magnesium levels before and during treatment. 5) EGFR saturation with cetuximab in skin samples.6) Kinase activity in skin samples before and after treatment

| 2528499 | ecrin-mdr-crc

Image Guided Treatment Optimization With Cetuximab for Patients With Metastatic Colorectal Cancer

Project description:In this study the investigators will evaluate the uptake of 89Zirconium labeled cetuximab in extra-hepatic colorectal metastases. The investigators hypothesize that uptake of 89Zr-cetuximab is required for response to cetuximab. If no uptake is present the investigators will escalate the dose cetuximab and repeat the 89Zr-cetuximab PET. The investigators will evaluate the clinical benefit rate of cetuximab in the patients with and without uptake. The ultimate goal is to create a selection tool that can predict response of cetuximab.

| 2164992 | ecrin-mdr-crc

ML29755 RNA-seq data

Project description:Programmed death-ligand 1 (PD-L1) expression has been associated with response to PD-1/PD-L1 inhibition, but responses are also seen in patients with PD-L1 negative tumors when assessed immunohistochemically (IHC) with various antibodies. To help elucidate these findings, we performed a positron emission tomography (PET) imaging study in human with the anti-PD-L1 antibody atezolizumab labeled with Zirconium-89 (89Zr) prior to treatment with atezolizumab to assess normal tissue distribution and evaluate tumor tracer uptake. Additionally, to help explain why some patients respond to checkpoint inhibitors despite low or absent PD-L1 expression, we compared PD-L1 expression and immune phenotypes based on both CD8 IHC and RNA sequencing of post-tracer biopsies to tumor tracer uptake (SUVmax).

2018-06-12 | GSE115594 | GEO

Functionele beeldvorming bij kanker van de dikke darm of endeldarm.

Project description:Interventions: 1. MRI-scan; 2. FDG-PET-scan. Primary outcome(s): Response at systemic treatment on CT. Study Design: N/A: single arm study, N/A , unknown, Other

| 16086 | ecrin-mdr-crc

Utility of FDG-PET Scan on the Selection of Patients for Resection of Hepatic Colorectal Metastases

Project description:Objective(s) of the proposed study: * The evaluation of the efficiency of 18F deoxyglucose-Positron Emission Tomography (FDG-PET) in staging patients eligible for hepatic resection of colorectal liver metastases in a randomized clinical multicentre setting. Research questions of the proposed study: * What are the effects and costs for patients with liver metastases of colorectal cancer indicated for potentially curative hepatic resection, using the conventional diagnostic strategy with computed tomography (CT) scan in comparison to the experimental diagnostic strategy incorporating FDG-PET scan (CT + FDG-PET scan), based on a health care perspective and a time horizon of 9 months. More specifically: * Does the experimental diagnostic strategy which includes FDG-PET scan in the diagnostic work-up of patients eligible for potentially curative hepatic resection of colorectal liver metastases lead to a better disease-free survival at 9 months after hepatic resection in comparison to the conventional diagnostic strategy using CT scan without FDG-PET scan. * What are the costs of diagnostic and therapeutic care for the two diagnostic strategies for patients eligible for potentially curative hepatic resection of colorectal liver metastases. * What is the effect of including the FDG-PET scan in the diagnostic work-up of patients eligible for potentially curative hepatic resection of colorectal liver metastases after hepatic resection, expressed as disease-free survival at 9 months adjusted for quality of health (Q-TWIST), in comparison to the use of CT scan only.

| 2013478 | ecrin-mdr-crc

Pinverin Application Trial to Reduce Bowel Uptake of FDG (Fluorodeoxyglucose)

Project description:1. Background 1. PET/CT (positron emission tomography/computed tomography) using FDG (fluorodeoxyglucose) is widely used for evaluation of cancer patients. 2. Bowel uptake of FDG is a serious problem that hampers the proper reading of PET/CT. 3. There is no widely-accepted method to reduce the bowel FDG uptake. 2. Purpose 1. To know whether pinverin (pinaverium bromide) application during PET/CT can reduce bowel uptake of FDG. 2. Pinverin is a calcium-channel blocker that ameliorates the bowel contraction. 3. Pinverin may be useful to reduce bowel FDG uptake by ameliorating the bowel contraction during PET/CT acquisition. 3. Method 1. Intervention versus control: administration of single tablet of pinverin (50mg) perorally versus simple water (~100mL). 2. Timing of administration: At the time of FDG injection. PET/CT images will be acquired 1hr post FDG injection. 4. Primary outcome 1. SUV (standardized uptake value) difference between pinverin administered patient group versus control group. 2. SUV (standardized uptake value) is calculated as: (decay corrected radioactivity in mCi/mL) x (body weight in g) / (injected radioactivity in mCi)

| 2169319 | ecrin-mdr-crc

AMPETOOR1

Project description:We hypothesised that in esophagogastric junction adenocarcinomas combining molecular predictive biomarkers with FDG-PET would optimise response prediction. Changes in FDG uptake in tumours meaured by PET scans after 14 days of chemotherapy define metabolic responders and non-responders. However while <5% of metabolic non-responders will go onto have a response to the full 9-12 week chemotherapy protocol providing a high negative predictive value for FDG-PET, the positive predictive value of metabolic response is more limited. Only 50% of those patients that have a metabolic response determined by FDG PET at day 14 will go on to subsequently have a response to the full 9-12 week chemotherapy protocol . We used global gene expression profiling to identify molecular biomarkers that when combined with FDG-PET would improve predictive accuracy, in particular we aimed to identify molecular biomarkers that could sub-classify FDG PET defined metabolic responders into those that did and did not subsequently go on to have a radiological response and hence clinical benefit from the full chemotherapy protocol. Patients with stage IB-IV esophagogastric junction adenocarcinomas(n=28) received platinum combination chemotherapy .FDG-PET CT scans were performed at baseline and day 14 and expression profiling (Affymetrix ST1.0 Exon Genechips) on baseline tumour biopsies. 14 patients were classified as FDG-PET metabolic responders and gene expression was analysed in these tumour specimens to determine differences between those that did subsequently go on to have a radiological response (n=10) or did not have a radiological response (n=4) to the full 9-12 week chemotherapy protocol. A tissue microarray(n=154 esophagogastric adenocarcinomas who underwent surgery+/-neoadjuvant chemotherapy)was used with immunohistochemistry for qualification of gene expression profiling results. Radiological response was assessed after 3or4 cycles of chemotherapy by RECISTv1.1.

2012-12-01 | E-MEXP-3730 | biostudies-arrayexpress

Gene expression profiles of the standardized uptake value in 18F-fluorodeoxyglucose positron emission tomography in tripple negative breast cancer

Project description:The standardized uptake value (SUV), an indicator of the glucose uptake degree in 18F-fluorodeoxyglucose positron emission tomography (FDG-PET), has been used as a prognostic factor in malignant tumors. We aimed to identify a signature reflecting prognostic SUV characteristics in triple negative breast cancer (TNBC). Transcriptome profiling was performed to identify a signature associated with the SUV in TNBC patients who underwent preoperative FDG-PET. We defined a signature significantly associated with the SUV (|r| > .35; P < .01). The SUV signature showed independent clinical utility for predicting BRC prognosis. Integrative analysis demonstrated a significance of the signature in predicting the response to immunotherapy and revealed that a signaling axis defined by TP53-FOXM1 and its downstream effectors in glycolysis-gluconeogenesis, including LDHA, might be important mediators in the FDG-PET process. Our results reveal characteristics of glucose uptake captured by FDG-PET, supporting an understanding of glucose metabolism as well as poor prognosis in TNBC patients with a high SUV.

2020-03-18 | GSE135565 | GEO

Expression profile of Ewing sarcoma

Project description:The expression profile in Ewing tumors was analyzed and correlated with glucose uptake (SUVmax) measured in 18F-FDG-PET imaging

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