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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),…

Evaluation of 18F-FDHT PET/CT as a predictor of response in patients with metastasized castration-resistant prostate cancer to be treated with enzalutamide.

Primary objective: to explore 18F-FDHT PET/CT as a predictor of response in patients with metastasized CRPC to be treated with enzalutamide. Secondary objective: to explore 18F-FDHT PET/CT as a predictor of clinical survival endpoints in patients…

The safety and efficacy of Methylene Blue MMX® modified release tablets administered to subjects undergoing screening or surveillance colonoscopy.

Evaluation of the histologically proven adenoma or carcinoma detection rate in patients undergoing a full colonoscopy with and without mucosal contrast enhancement, obtained with 200 mg of Methylene Blue MMX® tablets. The lack of mucosal contrast,…

Uniform FDG-PET guided gradient dose prescription to reduce late radiation toxicity (UPGRADE RT): a randomised controlled trial with dose reduction to the elective neck in head and neck squamous cell carcinoma

The UPGRADE-RT trial will investigate whether de-escalation of the elective radiation dose and introduction of an intermediate dose-level in the treatment of head and neck cancer will results in less radiation sequelae and improved quality of life…

Non-invasive nodal staging in breast cancer with MRI Lymphography using gadofosveset.

The aim of this pilot-study is to examine the accuracy of MRL compared to current nodal staging methods. We expect anacceptable accuracy of the MRL based on earlier studies with gadofosveset enhanced MRI in rectum cancer patients. Then the MRL could…

Value of multiparametric MR and MRI-guided biopsies of the prostate in men with an elevated PSA

To investigate the additional value of MRI and MRI-guided biopsy in men with an elevated PSA in the general practitioners* (GP) practice regarding the detection of both insignificant and significant cancer, and reduced biopsies.

Diagnostic value of novel MR imaging techniques for the primary staging and restaging of rectal cancer

The primary objectives are to determine the diagnostic performance of gadofosveset-enhanced T1-weighted MR imaging for the discrimination between pN0 and pN+ patients for both primary staging and restaging after chemoradiotherapy and to determine…

STATEC: A randomised trial of non-selective versus selective adjuvant therapy in high risk
endometrial cancer

To determine the clinical effectiveness of adjuvant therapy given to all unstaged (no lymph node dissection) high risk stage 1 endometrial cancer, compared with only node positive (staged) cases as judged by full lymph node dissection.

The influence of micrometastases on prognosis and survival in stage I-II colon cancerpatients: the EnRoute+ study

The purpose of the study is to delineate the upstaging percentage of pN0 patients by detection of micrometastases (pN0micro+) and evaluate the benefits from adjuvant chemotherapy on disease recurrence in pN0micro+ CC patients.

An open label, multi-center, phase 3 study with corresponding blinded image reading to determine the efficacy and safety of a single intravenous injection of 0.1 mmol/kg body weight of gadobutrol 1.0 molar (Gadovist®) in patients with newly diagnosed breast cancer referred for contrast-enhanced breast MRI

To assess the effectivity and safety of 1.0 molar gadobutrol (Gadovist®) for breast MRI

Phase III randomized trial with neoadjuvant chemotherapy (TAC) with or without zoledronic acid for patients with large resectable or locally advanced HER2-negative breast cancer.

In this study we want to investigate whether the submission of zoledronic acid to neoadjuvant chemotherapy benefits the pathological complete response, and thus favors a better clinical outcome in patients with large ressectable or locally advanced…

Evaluation of Indocyanine Green (ICG) enhanced Near-InfraRed Fluorescence (NIRF) Imaging for Intra-Operative Sentinel Lymph Node (SLN) detection in Breast Surgery.

This study aims at evaluating whether indocyanin green (ICG) enhanced intra-operative near-infrared fluorescence (NIRF) imaging is as good as or even better than the standard technique (technetium-99 labeled colloid and Patent Blue) in detecting…

Phase III, Multicenter, Double-blind, Randomized, Crossover Study to Compare MultiHance with Magnevist in Contrast-Enhanced Magnetic Resonance Imaging (MRI) of the Breast.

Primary Objective: To show superiority of a 0.1 mmol/kg dose of MULTIHANCE over a 0.1 mmol/kg dose of MAGNEVIST for breast MRI in terms of sensitivity for the diagnosis of malignant lesions compared with histopathology. Secondary Objectives: a)To…

Multicenter, randomized, open-label, clinical study on the agreement of Scintimun® Granulocyte and labeled 99m Tc-White Blood Cells in diagnosing infection/inflammation by immunoscintigraphy in peripheral bone and joints with suspected osteomyelitis.

The primary objective of the present study is to assess the agreement rate of Scintimun® Granulocyte and 99mTc-WBCs with regard to the diagnosis of infection/inflammation by immunoscintigraphy, based on the evaluations of three blinded and…

Sentinel node biopsy in Low- and Intermediae endometrial cancer Management: The SLIM-study

1. To assess the feasibility of SLN identification in endometrial cancer.2. To examine in how many cases SLN biopsy provides results that will tailor adjuvant treatment3. To investigate if SLN biopsy in women with low- and intermediate-risk…

Optimisation of [68Ga] PSMA-11 PET/CT Imaging Protocol for localizing primary prostate cancer prior to radical prostatectomy

The primary objective is to determine the optimal pharmacokinetic model of 68Ga-PSMA PET/CT, so 68Ga-PSMA PET/CT results can be quantified in prostate cancer.The secondary objectives are to determine whether the optimal kinetic model of 68Ga-PSMA…

A phase III, multicenter, randomized, open-label study of oral LDK378 versus standard chemotherapy in adult patients with ALK-rearranged (ALK-positive) advanced non-small cell lung cancer who have been treated previously with chemotherapy (platinum doublet) and crizotinib

The primary objective is to compare the antitumor activity of LDK378 versus reference chemotherapy.The key secondary objective is to compare Overall Survival (OS) in patients treated with LDK378 versus reference chemotherapy (pemetrexed or docetaxel…

A confirmatory, prospective, open-label, single-arm, reader-blinded multi-centre phase 3 study to assess the diagnostic accuracy of Ferumoxtran-10-enhanced Magnetic Resonance Imaging (MRI) and unenhanced MRI in reference to histopathology in newly-diagnosed prostate cancer (PCA) patients, scheduled for radical prostatectomy (RP) with extended pelvic lymph node dissection (ePLND)

Primary Objectives1. To confirm superiority of Ferrotran®-enhanced MRI over unenhanced MRI in sensitivity to detect metastases in normal size pelvic lymph nodes in using histopathology after lymph node dissection as established reference method (…

A confirmatory, prospective, open-label, multi-centre phase 3 study to evaluate diagnostic performance of 89Zirconium-labelled girentuximab (89Zr-TLX250) to non-invasively detect clear cell renal cell carcinoma (ccRCC) by positron emission tomography/CT (PET/CT) imaging in patients with indeterminate renal masses (ZIRCON study)

Primary Objective:To evaluate sensitivity and specificity of qualitative assessment of PET/CT imaging with 89Zr-TLX250 to non-invasively detect ccRCC in patients with indeterminate renal masses, using histology as standard of truth.Secondary…

High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)

This study has been transitioned to CTIS with ID 2024-514917-36-00 check the CTIS register for the current data. PRIMARY OBJECTIVES*Rx-induction: Comparison of the 3 year EFS rate of 2 induction regimens, GPOH and RAPID COJEC, in patients with high-…