Neoplasms

All Conditions

Rare Diseases

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Cilengitide + SoC (Temolozomide + Radiotherapy)

Subjects will receive cilengitide monotherapy for 2 weeks (Weeks 1 and 2); thereafter, cilengitide will be given in combination with the standard treatment regimen during Weeks 3 to 36. The standard combination treatment of radiotherapy (RTX) plus Temolozomide (TMZ) will be administered for a maximum of 6 weeks (Weeks 3 to 8), followed by TMZ maintenance treatment starting 4 weeks after RTX (i.e., Week 13) for up to 6 cycles, 4 weeks per cycle.

Cilengitide monotherapy treatment will be given to subjects in Group A for another 10 months as maintenance treatment (Weeks 37 to 78). Subjects in Group A may continue to receive cilengitide maintenance treatment beyond 10 months (beyond Week 78) until occurrence of progressive disease (PD) or unacceptable toxicity, or withdrawal for any other reason. A 28-day safety follow-up will be performed after the last dose of cilengitide.

Drug (including placebo)

In the first two weeks, treatment of subjects in Group B will be in line with the SoC. Thereafter the standard combination treatment of radiotherapy (RTX) plus Temolozomide (TMZ) will be administered for a maximum of 6 weeks (Weeks 3 to 8), followed by TMZ maintenance treatment starting 4 weeks after RTX (i.e., Week 13) for up to 6 cycles, 4 weeks per cycle.

Standard therapy

Ute Klinkhardt, MD

The main purpose of this clinical trial is to find out if cilengitide has an effect on brain tumor cells but also particularly on the blood vessels supplying the tumor with nutrient and oxygen in patients newly diagnosed with non-resectable (inoperable) glioblastoma.

In addition, this clinical trial will investigate if the addition of cilengitide in combination with standard treatment prolongs life in patients with non-resectable glioblastoma. Similarly, the duration of response of the cancer to this treatment and the side effects of the therapy will be analyzed. Furthermore, additional data on how the body deals with this substance will be collected (this is called pharmacokinetics or pharmacokinetic (PK) analysis). In this clinical trial the investigators would also like to learn more about the disease and the response to the experimental medication by measuring certain "markers".

This imaging trial will investigate the biological effects of cilengitide monotherapy on the tumor microvascular function and tumor viability in a homogenous non-pretreated subject population with newly diagnosed Gliobastoma (GBM). The purpose of this clinical trial is to study the effect that cilengitide may have on certain markers of cancer in your tumor and/or blood and to learn if there are any disease-related markers that could help in predicting how subjects respond to the administration of cilengitide.

The investigators anticipate that approximately 30 subjects will participate in this clinical trial. The clinical trial will be conducted in approximately 4 medical centers in the following countries: Germany, Poland, and Switzerland. The investigators anticipate the clinical trial will last until the end of 2013. Your participation in the trial may last up to 86 weeks.

Cilengitide Imaging Trial in Glioblastoma

A Multi-center, Open-label, Randomized, Controlled Phase I Trial to Investigate the Effects of Cilengitide (EMD 121974) Using Dynamic MR and FET-PET Imaging as a Pharmacodynamic Measure of Response in Subjects With Newly Diagnosed Glioblastoma

Any change in tumor kinetic model parameter (maximum increase in ktrans) to assess the tumor microvasculature structure and function

Any change in tumor kinetic model parameter (maximum change in vp) to assess the tumor microvasculature structure and function

Assessment of tumor amino acid (FET) uptake (tumor viability)

Change in total tumor volume and enhancing tumor volume as a measure of the overall level of tumor perfusion during the first 2 weeks of treatment with Cilengitide monotherapy

Change in the tumor extravascular extracellular space volume during the first 2 weeks of treatment with Cilengitide monotherapy

Change in perfusion parameter ADC during the first 2 weeks of treatment with Cilengitide monotherapy

Change in FA during the first 2 weeks of treatment with Cilengitide monotherapy

Change in tumor amino acid (FET) uptake kinetics during the first 2 weeks of treatment with Cilengitide monotherapy

Change in Absolute T1(mean spin-lattice relaxation time of unbound protons in water) during the first 2 weeks of treatment with Cilengitide monotherapy

Merck KGaA, Darmstadt, Germany

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

All subjects are included in the same arm.

Subjects receive a study-specific dynamic MRI scan. If the hypothesis of the study is confirmed, this examination can be used to inform future patients' treatment planning, replacing the use of 4D CT.

Dynamic MRI

Mattias Hedman, MD PhD

Eva Onjukka, PhD

Mattias Hedman, MD/PhD

The study aims to develop an improved method to tailor the geometric safety margin when treating with stereotactic body radiotherapy (SBRT), to avoid tumour cells being missed during irradiation and to limit the exposure of normal tissues as much as possible. Dynamic magnetic resonance imaging (MRI) is assumed to represent the tumour motion during the respiratory cycle more realistically, compared to 4-dimensional computed tomography (4D CT), thanks to its high temporal resolution and the possibility to image the motion over a longer period of time. Patients receiving SBRT for a pulmonary target located below the level of the carina are included in the study, and the hypothesis will be tested through a comparison of the tumour amplitude measured with each modality. Furthermore, the predictive value of the image series acquired at treatment planning, for the motion patterns observed at each treatment fraction, will be evaluated through repeated 4D CBCT acquisitions.

In the current study, a 2D-cine MRI examination will be performed, in addition to the 4D CT examination that is standard for patients receiving radiotherapy for tumours in the thorax or abdomen. A subgroup of the study participants (referred to as the 4D CBCT subcohort) will also be required to perform a 4D CBCT examination at three treatment sessions. The main cohort consists of 95 subjects and the 4D CBCT subcohort of 55 subjects. The study does not involve any change in the treatment routine; rather, the study images are collected for retrospective analysis. Following each imaging session, the subject should fill out an anxiety questionnaire and their pulse will be measured, to give an indication of any anxiety which might influence the breathing pattern of the current session.

Clinical follow-up will be performed retrospectively by reviewing the participants' medical records. Progress, health status and treatment-related toxicity will be evaluated, up to 10 years after completed treatment.

The study objectives are:

* To evaluate dynamic MRI for characterising the respiratory-related tumour motion, compared to the current standard modality of 4D CT.
* To evaluate the variation in breathing motion at different times points.
* To evaluate the clinical outcome.

RealMove (Lung): Assessing Tumour Motion With Dynamic MRI

The two dynamic scans represent the tumour motion through different techniques. If the amplitude indicated by 4D CT is smaller than that indicated by dynamic MRI, the hypothesis is confirmed.

4D CBCT images are acquired at each treatment session, in treatment position. These will assess the stability of the breathing patter through the treatment course.

The breathing pattern is represented by a probability density function, indicating the regularity of the motion. The stability of this pattern through the treatment course will be assessed.

Uppsala University Hospital

Region Stockholm

Blood and Lymph Conditions

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Tiffany Ting-Fang Shih, MD

Tiffany Ting-Fang Shih, M.D.

In malignant or neoplastic disease, angiogenesis is defined as the generation of new capillaries from preexisting blood vessels, e.g. by sprouting or by intusseption. Through the pioneering work of Folkman, it was recognized that angiogenesis plays an important role in tumor development, progression, and metastasis. It is also conceivable that there are forms or developmental stages of leukemia, multiple myeloma, or lymphomas that will progress independently of angiogenesis. Synthesis of angiogenesis activators, such as vascular endothelial growth factor (VEGF) and other angiogenic factors, such as basic fibroblast growth factor (bFGF), has been demonstrated for leukemia cells, non-Hodgkin's lymphoma, and myeloma cells. Microvessel density is also significantly elevated over normal controls with progressive increases according to the stages of myelodysplastic syndrome. Increased microvessel density (MVD) in the bone marrow was found in patients with multiple myeloma in comparison to normal controls and increased MVD is an adverse prognostic marker in multiple myeloma. However, the functional status of the blood vessel (e.g. permeability) cannot be determined by the above mentioned methods.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cilengitide Imaging Trial in Glioblastoma	NCT01558687	Supratentorial ...	Drug (including... Standard therap...	18 Years - 70 Years	Merck KGaA, Darmstadt, Germany
RealMove (Lung): Assessing Tumour Motion With Dynamic MRI	NCT06322329	Lung Tumor	Dynamic MRI	18 Years -	Region Stockholm
Cilengitide Imaging Trial in Glioblastoma	NCT01558687	Supratentorial ...	Drug (including... Standard therap...	18 Years - 70 Years	Merck KGaA, Darmstadt, Germany
Bone Marrow Angiogenesis in Acute Myeloid Leukemia - Evaluated by Dynamic Contrast Enhanced Magnetic Resonance (MR) Image	NCT00172562	Acute Myeloid L...		20 Years - 80 Years	National Taiwan University Hospital
RealMove (Lung): Assessing Tumour Motion With Dynamic MRI	NCT06322329	Lung Tumor	Dynamic MRI	18 Years -	Region Stockholm
Bone Marrow Angiogenesis in Acute Myeloid Leukemia - Evaluated by Dynamic Contrast Enhanced Magnetic Resonance (MR) Image	NCT00172562	Acute Myeloid L...		20 Years - 80 Years	National Taiwan University Hospital

Spots Global Cancer Trial Database for dynamic mri

Every month we try and update this database with for dynamic mri cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for dynamic mri

Every month we try and update this database with for dynamic mri cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for dynamic mri cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.