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A phase 1, randomized, double blind, placebo-controlled, single ascending dose study to assess safety, tolerability and pharmacokinetics of cRGD-ZW800-1 intravenous injection in healthy volunteers

Primary objective- To determine safety and tolerability of a single dose of cRGD-ZW800-1 in healthy volunteers.Secondary objectives- To determine the pharmacokinetics of a single dose of cRGD-ZW800-1 by measuring the fluorescence of blood and urine…

An open-label, randomised, non-comparative phase 2 study evaluating S 95005 (TAS-102) plus bevacizumab and capecitabine plus bevacizumab in patients with previously untreated metastatic COlorectal cancer who are non-eligible for intensive therapy (TASCO1 study)

This study will evaluate 2 different treatment strategies : a combination of S 95005 and bevacizumab (experimental combination) and a combination of capecitabine and bevacizumab (control arm) as first-line treatment for metastatic colorectal cancer…

Pathogenic microbes: an exploration for their driving role in colitis associated cancer

To identify pathogenic bacterial biofilms in UC-patients with and without neoplasia in tandem with host factors such as barrier defects and carcinogenic pathway activation in a prospective cohort study.

89Zr-AMG211 PET imaging in patients with relapsed/refractory gastrointestinal adenocarcinoma before and during treatment with AMG 211.

Primary objective: To evaluate the in vivo biodistribution (measured in SUV) and quantitative radioactivity in organs of 89Zr-AMG211 in patients with relapse/refractory gastrointestinal adenocarcinoma as assessed by PET/CT. Secondary objectives: I)…

A Phase I, double-blind, randomised, placebo-controlled, multiple dose study to evaluate the safety, pharmacokinetics and pharmacodynamics of two dosages of estetrol in healthy men

Primary objectives:* To investigate the safety of multiple dosages of E4;* To investigate the efficacy of multiple dosages of E4 on hormone levels related to prostate function.Secondary objectives:* To investigate the pharmacodynamic effects of E4…

Validation of optical frequency domain imaging (OFDI) bronchoscopy as a diagnostic imaging modality to characterize pulmonary lesions

To validate OFDI bronchoscopy as a diagnostic imaging modality to characterize pulmonary lesions.

Inguinal or Ilio-inguinal Lymphadenectomy for Patients With Metastatic Melanoma to Groin Lymph Nodes and no Evidence of Pelvic Disease on PET/CT Scan - A Randomised Phase III Trial (EAGLE FM)

This study aims to provide a more rational evidence base for appropriate management for metastatic melanoma in the groin LNs, through assessing the effect of the addition of ipsilateral pelvic lymphadenectomy on patient disease-free survival (DFS),…

Creatine kinase, platelet aggregation, and bleeding risk in women with uterine leiomyomas

Main study:We want to assess whether bleeding risk in women with uterine leiomyomas is associated with CK activity and attenuated platelet aggregation.Objective of pilot study:Firstly, to perform a feasibility pilot of CK/AK measurement in menstrual…

Optimizing accelerometer data analysis to assess physical activity and sedentary behavior among breast cancer survivors: a laboratory study

1. To validate accelerometer cut-points to asses physical activity and sedentary behavior of breast cancer survivors. 2. To investigate the validity of accelerometers, inclinometers, heart rate and oxygen consumption to assess time spent in…

DW-MRI in mediastinal restaging after concomitant chemoradiotherapy and prognosis of trimodality treatment for stage IIIA/B NSCLC with mediastinal lymph node metastases and without supraclavicular lymph node metastases ; NSCLC Stadium IIIA/B N2/3

This study aims to investigate the feasability to use DW-MRI for mediastinal restaging after concomitant chemoradiotherapy and the feasabilitiy to predict whether or not mediastinal downstaging will be achieved during concomitant chemoradiotherapy…

Exploring the metabolic profile of neuroendocrine tumors

The aim of this study is to explore the added value of the indol profile in comparison to serotonin in platelets and 5-HIAA in urine for diagnosis and potentially management of neuroendocrine tumors including gastrinomas, pNETs and brochopulmonary…

89Zr-pembrolizumab-PET imaging in patients with locally advanced or metastatic melanoma or non-small cell lung cancer

Primary objective: To evaluate whole body distribution of 89Zr-pembrolizumab in patients with locally advanced or metastatic melanoma or NSCLC. Secondary objectives: i) To evaluate pharmacokinetics of 89Zr-pembrolizumab; ii) To assess the…

Free circulating tumour DNA in patients with peritoneal metastases of colorectal origin and HIPEC therapy; LIBEC trial - a feasibility study

To evaluate the detection ctDNA in patients with PC of colorectal origin undergoing cytoreductive surgery and HIPEC at time of diagnosis in a feasibility trial This study is considered feasible:1. If in at least 70% of the patients ctDNA status…

A Phase I, Open-label, Single Dose Study to Evaluate the Disposition, Metabolism, and Excretion of Radiolabelled [14C]-BIM23B065 Following Subcutaneous Administration in Healthy Male Subjects

The purpose of the study is to investigate how quickly and to what extent BIM23B065 is distributed, metabolized (broken down) and excreted from the body, and what the main route of excretion from the body is (urine or feces); this is called…

89Zirconium-labeled nivolumab and 18F-labeled anti-PD-L1 as predictive imaging biomarkers of response and toxicity in nivolumab treated patients with non-small-cell lung cancer * a feasibility study

To assess uptake of 18F-PD-L1 and 89Zr- nivolumab in tumor lesions.

Melanoma, artificial reproductive therapy and pregnancy; is there an increased risk of recurrence?

The aim of this study is to evaluate if a recurrent melanoma is more common after ART or pregnancy after a previous history of stage I or II melanoma. Other forms of hormonal therapy will be examined. Also, anxiety about pregnancy or hormonal…

Hypofractionated Focal Lesion Ablative Microboost in prostatE cancer (Hypo-FLAME)

The main goal of this phase II study is to investigate whether a focal ablative SBRT boost to the macroscopic tumor is feasible and associated with acceptable toxicity in addition to whole gland prostate SBRT. Based on the present study, a phase III…

Prevalence of gastrointestinal disorders in the general population 50 to 75 years in the Ommoord municipality: videocapsule in the Rotterdam study

What is the prevalence of gastro-intestinal disorders and which are the determinants?

Hepatic NET metastasis embolization biomarker evaluation

The purpose of this study is to evaluate the effect of local ablative treatment or embolisation or SIRT on circulating NET transcripts (PCR score or NETtest). In particular, the variation of circulating NET transcripts will be correlated to NET…

Intraoperative detection of tumor tissue in pancreatic cancer using a VEGF-targeted optical fluorescent imaging tracer

Part 1 1. Determine if accumulation of the fluorescent tracer bevacizumab-800CW can be detected for identification of pancreatic cancer tissue during surgery.2. Identify two doses of conjugate that provide the best visualization of tumor tissue…