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Personal history, physical examination including anthropometry with hip/waist-ratio, electrocardiogram, echocardiography, 1-minute-sit-to-stand test, questionnaires on health-related quality of life (SF-36), diet, physical activity, and fatigue

cardiac assessment

Claudia E Kuehni, MD

Christina Schindera, MD

Gabriela Kuster, MD

Stephan Dobner, MD

Thomas Suter, MD

Nana K Poku, MD

Reto Kurmann, MD

Eva Scheler, MD

This multicenter, prospective cohort study evaluates early cardiac dysfunction in adult survivors of childhood cancer. The hypothesis of this study is that cardiac dysfunction can be detected earlier when using speckle tracking echocardiography as novel echocardiographic technique compared to conventional echocardiography.

Cardiovascular disease including cardiac dysfunction is the leading non-malignant cause of death in childhood cancer survivors. Early detection of cardiac dysfunction is important to identify those in need for medical intervention to improve outcome. This study invites adult childhood cancer survivors to a clinical appointment to the University Hospital Bern, Switzerland. A detailed, standardized cardiac assessment including conventional and novel echocardiographic techniques (speckle tracking) as well as cardiopulmonary exercise testing is performed. Cardiac dysfunction is evaluated in survivors who have had cardiotoxic cancer therapy with anthracyclines and/or chest radiation (high risk) and in survivors who have had chemotherapy other than anthracyclines (standard risk).

Cardiac Dysfunction in Childhood Cancer Survivors

Prospective Single Center Cohort Study for Early Detection of Cardiac Dysfunction in Childhood Cancer Survivors

Conventional echocardiography: left ventricular ejection fraction (%)

Speckle tracking echocardiography: longitudinal (LS), circumferential (CS), and radial strain (RS)

Cardiopulmonary exercise testing: peak oxygen consumption, percent-predicted carbon dioxide production

Cumulative doses of anthracyclines, steroids, and alkylating agents (mg/m2)

University Hospital, Basel, Switzerland

University Children's Hospital Basel

Insel Gruppe AG, University Hospital Bern

Cantonal Hospital of St. Gallen

Luzerner Kantonsspital

University Hospital, Geneva

University of Bern

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

CT Scan

Lung CT

Walk Test

SGRQ

Biological Sample Collection

Toxicity

Cardiac Assessment

Shruti Jolly, M.D.

Little is known about the safety of body radiation therapy (SBRT), especially the impact on pulmonary function, quality of life, and on functional changes within the lung itself. Radiation dose constraints and capturing functional changes on imaging are not well studied in this setting.

The current study aims to evaluate the utility of advanced imaging to measure lung function prior to and after treatment and to assess the feasibility of using this data to adapt SBRT planning.

Stereotactic body radiation therapy (SBRT) is becoming a new standard for unresectable lung metastases and primary lung cancers.

However, it is becoming increasingly common for patients to undergo multiple courses of lung SBRT to synchronous and/or metachronous lung lesions. Further, the indications for SBRT are being expanded to patients who have very poor pulmonary function such as FEV1 \< 0.5 L or DLCO \< 35% predicted, who have large tumors (\>3 cm), or who have centrally located lesions that abut great vessels and mainstem bronchi. Little is known about the safety of such treatments, especially the impact on pulmonary function, quality of life, and on functional changes within the lung itself. Radiation dose constraints and capturing functional changes on imaging are not well studied in this setting.

The current study aims to evaluate the utility of advanced imaging to measure lung function prior to and after treatment and to assess the feasibility of using this data to adapt SBRT planning. SPECT/CT will be used to measure ventilation and perfusion changes while. CT ventilation scans will be used to correlate functional changes observed on diagnostic SPECT/CT. Dynamic contrast enhanced MRI (DCE-MRI) will also be used to explore local vascular changes in the treated tumor. In patients whose tumors lie close to the heart, cardiac MRI will be used to investigate whether high doses of radiation per fraction are associated with changes in cardiac function. These imaging modalities may be used to potentially predict toxicity and patient response with the ultimate goal of prospectively adapt dose to individual patient and tumor characteristics. Lung function prior to and post-treatment will also be measured as a correlate of functional imaging changes. Identifying areas of the lung that are sub-functional or low-functioning may offer an opportunity to adapt stereotactic ablations that spare functional lung thereby making SBRT treatments to higher risk patients safer.

Patients will have 20 mL of blood collected by venipuncture at the specified time points.

Functional Imaging in Lung SBRT

Functional Outcomes for Stereotactic Body Radiotherapy of Lung Lesions in High Risk Patients

To explore if SBRT tumors that lie within 2 cm of the heart cause any changes in cardiac function on cardiac MRI

To characterize longitudinal changes in lung function using SPECT/CT and CT ventilation scans in "high risk" patients undergoing standard SBRT treatments.

To explore radiation dosimetric predictors and correlates of SPECT-CT and CT ventilation functional imaging that predict toxicity in these patients.

To determine if early functional changes in SPECT-CT correlate with changes in CT ventilation, pulmonary function and patient reported decrements in lung function on the St. George Respiratory Questionnaire (SGRQ).

To assess early vascular changes using DCE-MRI in the lung tumor treated with SBRT as a possible predictor of tumor response.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cardiac Dysfunction in Childhood Cancer Survivors	NCT03790943	Cardiac Dysfunc... Cardiovascular ... Childhood Cance...	cardiac assessm...	18 Years -	University of Bern
Cardiac Dysfunction in Childhood Cancer Survivors	NCT03790943	Cardiac Dysfunc... Cardiovascular ... Childhood Cance...	cardiac assessm...	18 Years -	University of Bern
Functional Imaging in Lung SBRT	NCT03121300	Lung Cancer	CT Scan Lung CT MRI Walk Test SGRQ Biological Samp... Toxicity Cardiac Assessm...	18 Years -	University of Michigan Rogel Cancer Center

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