Neoplasms

All Conditions

Wounds and Injuries

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Adenocarcinoma

Radiation Injuries

Prostatic Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Vasoconstrictor Agents

Respiratory System Agents

All Drugs and Chemicals

Epinephrine

Racepinephrine

Epinephryl borate

patients treated for a prostate adenocarcinoma

70 ml per patient for collection of biological sample

Whole blood sample

Jean Marc SIMON, PH

Background:

Between 2000 and 2006, 433 patients were overexposed (8% to 10%) during a course of conformal radiotherapy for a prostate adenocarcinoma in Jean MONNET hospital, Epinal, France. Among them, twenty four patients received an additional mean dose about 20%, due to an inappropriate use of the treatment planning system. Severe adverse events (proctitis, cystitis, and tissue necrosis) have occurred among most of these overexposed patients. We propose to develop several research programs in order to increase the scientific knowledge on iatrogenic effects related to overexposure of ionizing radiation, by studying their relationship with dosimetric, clinical, biologic and genetic characteristics.

Aim of the study:

To correlate the received doses, the volume of irradiated normal tissues, the events, with biologic, phenotypic and genetic data.

Primary study endpoint:

Incidence and severity of adverse events related to radiotherapy (according to SOMA - LENT and CTCAE scales).

Secondary study endpoint:

* Correlation between adverse events and radiation doses with biologic, phenotypic and genetic data.
* Evaluation of T-lymphocyte apoptosis to predict radiation-induced late toxicity
* Gene associations with risks for adverse events related to radiotherapy
* Levels of circulating microparticles and bystander effect after irradiation

Inclusion criteria:

Consecutive patients treated for a prostate adenocarcinoma in the radiation department of the Jean MONNET Hospital between 2000 and 2006.

Potential. Better identification of patients at high risk of adverse events related to radiotherapy.

Patients Overexposed for a Prostate Adenocarcinoma

Surveillance of the Cohort of Patients Overexposed in a Course of Conformational Radiotherapy for a Prostate Adenocarcinoma in Jean MONNET Hospital, Epinal, France. Epinal: Patients Overexposed for a Prostate Adenocarcinoma

Assistance Publique - Hôpitaux de Paris

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

The participants in this group will be receiving proton therapy of the affected breast and chest wall as part of their standard of care. In addition, a Computed Tomography (CT) Scan of the chest wall will be performed, and pulmonary function test (PFT).

The participants in this group will be receiving X-ray radiation therapy of the affected breast and chest wall as part of their standard of care. In addition, a Computed Tomography (CT) Scan of the chest wall will be performed, and pulmonary function test (PFT).

Proton bean radiation therapy interact differently with tissue with the result that protons are absorbed completely within the tissue instead of primarily passing through the entire body. The maximal depth of penetration is dependent upon the incoming velocity (energy) of the protons. Proton therapy utilizes this property to deliver radiation with very little dose beyond the targeted lesion. The dose-rate will be managed as part of the standard of care.

Proton beam radiation therapy.

The three-dimensional (3D) mapping of radiation dose distributions permits detailed assessment of local vascular damage as a function of treatment factors of dose, dose-rate. The dose-rate will be managed as part of the standard of care.

X-ray based radiation therapy

Computed Tomography (CT) Scan of the chest will be performed at 1, 3, 6, 12, 18 and 24 months

Computed Tomography (CT) Scan

Pulmonary function test (PFT) will be performed at pre-treatment, and at 6 and 12 months.

Pulmonary Function Test (PFT)

Walter O'Dell, PhD

Julie Bradley, PhD

Through improved early detection and treatment, the number of long term breast cancer survivors continues to increase. There are now 2.8 million breast cancer survivors in the U.S. Florida alone adds over 9,000 women to the survivorship pool each year. Most receive radiation treatment (RT) of the affected breast and chest wall to reduce risk of recurrence. Even with advanced radiation techniques for dose conformality to minimize exposure of the highly sensitive lung, 14% of breast cancer patients treated with radiation develop clinical pulmonary toxicity, with 4% overall experiencing high grade clinical toxicity. Early diagnosis and intervention to mitigate lung radiation toxicity is increasingly important for the long term care of these survivors.

The investigators' goal is to better identify breast cancer patients at high risk for experiencing severe pulmonary toxicity requiring medical intervention, provide a means to identify toxicity early on, and tailor treatment and/or early intervention on a per-patient basis.

This project involves repeat chest computed tomography (CT) imaging and blood draws in subjects with breast cancer with radiation treatment to the affected breast and chest wall. The investigators are studying women receiving one of 2 types of radiation, either conventional X-rays (IMRT) or protons at the University of Florida Health Proton Therapy Institute (UFHPTI). These subjects typically would not receive follow-up chest CTs as per standard of care. All subjects will have received a pre-treatment chest CT scan as part of the treatment planning process. The investigators will enroll 30 subjects in the X-ray treatment group and 25 subjects in the proton group.

The investigative team has recently solved the technical challenges of extracting and characterizing lung vascular anatomy from clinical CT images of the chest and used these tools to characterize acute and chronic changes to pulmonary vascular structure in breast cancer patients receiving radiation to the chest wall for treatment of their cancer.

In Aim 1 of this study the investigators will compare lung vascular damage in women treated with conventional radiation with those treated at the UFHPTI. In Aim 2 they will use blood samples of the subjects of Aim 1 to investigate the differential role of inflammatory cytokines in the initiation and progression of pulmonary vascular radiation response in conventional versus proton radiation exposures. Aim 3 compares vascular damage with clinical pulmonary function assessment using spirometry and diffusion capacity of carbon monoxide (DLCO). Aim 4 ties together Aims 1-3 by employing and extending existing mathematical models of radiobiological response to improve and solidify the scientific understanding of the biological mechanisms of radiation response.

Breast Cancer Lung Late Effects

Early Markers of Subclinical Pulmonary Vascular Radiation Toxicity in Breast Cancer

To identify patterns of asymptomatic metastatic progression in those subjects who develop recurrence to the thorax during the follow-up imaging period,

The investigators seek to identify differences between the treatment modalities (proton versus X-ray) in regards to the lower dose limits for change in number of small blood vessels as measured from chest CT scans and quantified using the team's analysis technique.

Identify change in number of small blood vessels as measured from chest CT scans and quantified using the team's analysis technique, as a function of radiation dose exposure across the lung.

Identify differences in temporal patterns of vessel regeneration following radiation exposure as a function of dose and of modality (proton versus X-ray).

Quantify differences in temporal patterns of levels of cytokines in the blood in breast cancer patients receiving conventional X-ray versus proton RT using serial blood draws that are time-matched with the CT chest scans.

Correlate change in number of small blood vessels as measured from chest CT scans and quantified using the team's analysis technique, with clinical pulmonary function test (spirometry and diffusion capacity for carbon monoxide) outcomes to identify potential predictive value of early vascular changes to conventional clinical measures of late effects.

The goal is to monitor long-term (\>8 year) incidence of clinical pulmonary toxicity in these subjects to identify any difference between X-ray and proton treatment methodologies.

The goal is to monitor long-term (\>8 year) survival in these subjects to identify any difference between X-ray and proton treatment methodologies.

Florida Department of Health

University of Florida

Symptoms and General Pathology

Nervous System Diseases

Recurrence

Brain Neoplasms

Body Weight

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Radiation Injury Recurrent symptoms after radiation therapy of a brain tumor are not always the result of tumor recurrence but may represent radiation necrosis of the brain.

Symptoms are the result of actual tumor recurrence

Pia M Sundgren, MD, Ph.D

The purpose of this study is to determine if certain MRI imaging sequences (pictures) are more helpful to the physicians in determining if a brain tumor has recurred or if the person has radiation injury following their treatment.

After a patient has been treated for a brain tumor by radiation the area of the brain that has been treated changes in appearance. These changes in appearance can make it hard to determine if a brain tumor has come back at the same site or if it is radiation injury. The purpose of this study is to determine if certain MRI imaging sequences (pictures) are more helpful to the physicians in determining if the tumor has come back or if it is radiation injury.

Differentiating Recurrent Brain Tumor Versus Radiation Injury Using MRI

Prospective Study Differentiating Recurrent Brain Tumor Versus Radiation Injury Using Magnetic Resonance (MR) Spectroscopy, Diffusion Tensor Imaging and Diffusion Weighted Imaging on 3T(Tesla) MR Scanner

The purpose of this study is to determine if certain MRI imaging sequences are more helpful to the physicians in determining if the tumor has come back or if it is radiation injury

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Patients Overexposed for a Prostate Adenocarcinoma	NCT00773656	Prostate Adenoc...	Whole blood sam...	18 Years -	Assistance Publique - Hôpitaux de Paris
Breast Cancer Lung Late Effects	NCT02725840	Radiation Injur... Breast Cancer	Proton beam rad... X-ray based rad... Computed Tomogr... Pulmonary Funct...	18 Years -	University of Florida
Breast Cancer Lung Late Effects	NCT02725840	Radiation Injur... Breast Cancer	Proton beam rad... X-ray based rad... Computed Tomogr... Pulmonary Funct...	18 Years -	University of Florida
Differentiating Recurrent Brain Tumor Versus Radiation Injury Using MRI	NCT00760409	Radiation Injur... Brain Tumor		18 Years -	University of Michigan
Breast Cancer Lung Late Effects	NCT02725840	Radiation Injur... Breast Cancer	Proton beam rad... X-ray based rad... Computed Tomogr... Pulmonary Funct...	18 Years -	University of Florida

Spots Global Cancer Trial Database for radiation injury