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Radiation Injuries clinical trials

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NCT ID: NCT02343133 Completed - Clinical trials for Hematopoietic Syndrome Due to Acute Radiation Syndrome

Safety Study of HemaMax™ (rHuIL-12) to Treat Acute Radiation Syndrome

Start date: January 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether HemaMax is safe and well tolerated to support efficacy under FDA's Animal Rule to reduce the morbidity and mortality associated with the hematopoietic syndrome of acute radiation syndrome.

NCT ID: NCT02212964 Completed - Radiation Injury Clinical Trials

Differentiation of Pseudoprogression and True Progression Through High Field Susceptibility Weighted Imaging and R2*

Start date: July 2014
Phase: N/A
Study type: Observational

Using a multi-echo gradient echo sequence to calculate R2* and quantitative susceptibility maps and well as susceptibility-weighted imaging post processing the investigators hypothesize that the investigators would be able to distinguish between pseudoprogression and true progression with the use of an easily implementable sequence on clinical MRI scanners.

NCT ID: NCT02152722 Recruiting - Radiation Injury Clinical Trials

Breath Test for Biomarkers in Humans Receiving Total Body Irradiation

Start date: September 2013
Phase: N/A
Study type: Observational

The effect of radiation on normal tissue varies widely between individuals. Consequently, a test to measure tissue response to radiation could be clinically useful by permitting more accurate titration of dosage in patients undergoing radiotherapy. Also, in view of emerging concerns about possible nuclear terrorism a test for exposure to radiation might also be useful in evaluating victims of a "dirty bomb" explosion. A number of different techniques have been previously reported in epidemiological studies for the estimation of prior radiation exposure. This study explores one approach to estimating radiation exposure by measurement of increased oxidative stress which can be detected by a breath test. In this study subjects undergoing significant exposure to therapeutic radiation will provide breath samples for analysis in a central laboratory. The hypothesis of the study is that the analysis of these samples will lead to the identification of a set of markers of radiation exposure.

NCT ID: NCT02104271 Completed - Radiation Injuries Clinical Trials

Comparison Between Two Different Parameters of Argon Plasma Coagulation in the Treatment of Chronic Radiation Proctitis: Historical Control Trial.

Start date: January 2013
Phase: Phase 2
Study type: Interventional

There is a wide variability of options for treatment of chronic radiation proctitis. However, studies are still limited, usually case reports from a single center and few are comparative studies between methods. Therefore, the choice of treatment is determined by availability and local expertise for each method. The variability of treatment options range from anti-inflammatory medical treatment, sucralfate, short chain fatty acids, antioxidants and hyperbaric oxygen to such endoscopic and surgical treatments. Surgery is usually the last therapeutic option due to the high morbidity and mortalityassociated. Various endoscopic treatment modalities have been reported. Formalin topic is effective in up to 48% of patients with chronic radiation proctitis. The endoscopic treatment with argon plasma (APC) is low cost, easy to apply and transportation, safe and effective in the treatment of rectal bleeding in patients with chronic radiation proctitis. Currently, the APC is the preferred endoscopic modality. Most studies on the use of APC in radiation proctitis showed benefit. The APC controls the mild to moderate rectal bleeding in 80% to 90% of cases and improves symptoms of urgency, diarrhea and tenesmus in 60% to 75% of cases.

NCT ID: NCT01742221 Completed - Clinical trials for Hematopoietic Syndrome Due to Acute Radiation Syndrome

Safety and Tolerability of HemaMax™ (rHuIL-12) as Radiation Countermeasure

Start date: August 2012
Phase: Phase 1
Study type: Interventional

This trial is designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of HemaMax in healthy male and female volunteers.

NCT ID: NCT01604512 Completed - Brain Cancer Clinical Trials

A Comparison of MRI Perfusion and FDG PET/CT to Distinguish Between Radiation Injury and Tumor Progression

Start date: May 2012
Phase: N/A
Study type: Interventional

This study will examine if MRI perfusion and PET/CT can tell growing tumor and radiation injury apart. MRI perfusion looks at the blood vessels in the tumor. PET/CT looks if the tumor cells are actively growing. The investigators will do these two tests and see which one is better. Patients will remain on study until the completion of either the MRI perfusion or PET/CT that are within 12 weeks of each other. After one of these scans, the patient will have no active interventions and will be off study. Optional: Restriction Spectrum Imaging (RSI) Sequence RSI sequence is an advanced way of looking at your brain. The scan allows doctors to see how water is moving within brain tumors or within brain cells. The extra sequence takes additional 4-5 minutes in the scanner. The RSI sequence is optional. The patient will only be asked to participate if the doctor believes that it will be helpful. Off study: Patients will remain on study until the completion of either the MRI perfusion or PET/CT that are within 12 weeks of each other. After one of these scans, the patient will have no active interventions and will be off study. Patients will obtain a standard of care brain MRI scan about every 2-3 months. These MRI scans will be used to track disease progression.

NCT ID: NCT01487954 Completed - Clinical trials for Stage IV Breast Cancer

Alkaline Water in Reducing Skin Toxicity in Women With Breast Cancer Undergoing Radiation Therapy

Start date: May 2010
Phase: Phase 2
Study type: Interventional

This phase II trial is studying how well alkaline water works in reducing skin toxicity in women with breast cancer undergoing radiation therapy. Alkaline water may reduce radiation therapy-related skin toxicity in patients with breast cancer.

NCT ID: NCT01334931 Completed - Radiation Injury Clinical Trials

Use of Large Field of View During Image Acquisition for Coronary Angiography

XRay Reduction
Start date: April 2011
Phase: Phase 3
Study type: Interventional

Coronary angiography exposes patients and physicians to ionizing radiation. The purpose of this study is to evaluate the routine use of large field of view during image acquisition for coronary angiography. Patients with indication of diagnostic coronary angiography will be randomized for the use of either large field of view during image acquisition or medium field of view. Patients, physician and nurse radiation exposure will be measured by digital dosimeter.

NCT ID: NCT01291433 Completed - Clinical trials for Radiation Induced Brachial Plexopathy

Trial of Combined Pentoxifylline-tocopherol-clodronate vs Placebo in Radiation-induced Brachial Plexopathy

PENTOCLO
Start date: March 2011
Phase: Phase 3
Study type: Interventional

Radiation-induced brachial plexopathy (RIP) is a rare and severe delayed peripheral nerve complication of radiotherapy, that is spontaneously irreversible with no medical treatment to limit or reduce symptoms. The investigators planed in RIP a randomized double blind clinical trial, using a pentoxifylline (P)- tocopherol (E)- clodronate combination versus placebo, to assess a possible symptomatic regression by a sensory-motor neurological quantifiable and reproducible score (modified Subjective Objective Medical management Analytic, SOMA). The investigators previously developed a successful PE treatment in symptomatic RI injuries via the antioxidant pathway, in clinical phase II and III trails and experiments obtaining a major significant radiation-induced fibrosis regression, then the PE clodronate combination (PENTOCLO), obtaining a rapid and significant healing of mandible osteoradionecrosis and significant neurological signs regression (- 35% modified SOMA score at 18 months) in 50 partial RIP. The aim of this phase III randomized clinical trial is to show PENTOCLO efficiency and its tolerance in long survival patients irradiated before for cancer and presenting with partial RIP of upper or lower legs. The investigators calculated to include 60 patients to show a significant clinical difference between the two groups after 18 months of treatment: PENTOCLO[Pentoxifylline 400 (2x/d) + vitamine E 500 (2x/d) + intermittent Clodronate 800 (2/d, 5d/7)] versus triple placebo, with prednisone 20 (2d/7) for all patients. RIP is assessed before treatment and every 6 months by a standardized sensory-motor neurological (SOMA 95 modified by NCI-CTC 99) score used for main criteria at M18, and various neurological scales of assessment (Visual Analog Scale for pain / VAS for paresthesia, Neuropathic Pain Symptom Inventory [NPSI], Overall Disability Sum Score [ODSS], muscle testing, Nine hole peg test / Timed 25-Foot Walk), quality of life (SF36, Patient Global Impression of Change and Clinical Global impression of Change [PGIC/ CGIC]) and electrophysiology.

NCT ID: NCT01216800 Recruiting - Clinical trials for Head and Neck Cancer

Intensity-Modulated Radiation Therapy or 3-Dimensional Conformal Radiation Therapy in Decreasing Hearing Loss in Patients Who Have Undergone Surgery for Parotid Tumors

Start date: August 2008
Phase: Phase 3
Study type: Interventional

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether intensity-modulated radiation therapy or 3-dimensional conformal radiation therapy is more effective in decreasing hearing loss in patients undergoing radiation therapy for parotid gland cancer. PURPOSE: This randomized phase III trial is studying intensity-modulated radiation therapy to see how well it works compared with 3-dimensional conformal radiation therapy in decreasing hearing loss in patients who have undergone surgery for parotid tumors.