The Added Value of Quantification of Lung Function in Patients Undergoing Radiotherapy, Using Tc-99m-MAA SPECT-CT

NCT03123679 | Unknown

• 1 other identifier: TASMC-17-ES-0723-CTIL
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Adult patients referred to radiotherapy treatment of primary or secondary malignant involvement of the lung parenchyma, who are not meeting the exclusion criteria, will be introduced to the study and suggested to participate in it by the radiotherapist, Dr Viacheslav Soyfer, M.D. from the Institute of Radiotherapy Tel Aviv (Sourasky) Medical Center. They will sign an informed consent and the study will be conducted based on the agreement of the institutional ethical committee, prior to perfusion study. Each patient will be evaluated three times: prior to treatment, a baseline evaluation mid-follow-up period 6 weeks post initiation of radiotherapy and a delayed follow up 6 months post treatment. Each SPECT/ Low dose CT assessment will take place within two weeks of the clinical and PFT assessment. The study will take place within a duration of two years, from recruiting the participating patients to the completion of the study protocol by the last recruited patient. For the individual patient, the duration of participation is six months. Perfusion SPECT/ Low dose CT studies with a non-diagnostic low dose chest CT will be performed after the I.V. injection of 4 mCi 99m-Tc-MAA. SPECT/ Low dose CT scan will be acquired immediately post injection on a GE OPTIMA NM/CT 640 camera. In order to obtain a better definition of the irradiated fields, we will co-register the SPECT/ Low dose CT with high-resolution CT provided from the Institute of Radiotherapy. In this procedure, the low dose chest CT is used as a bridge between high resolution CT and the functional imaging SPECT. Using the Q.Lung segmentation tool, individual whole lung function and lung subunits will be assessed, and will be correlated to irradiated fields. Calculated data for each study step will be compared in order to assess the extent of RT induced lung injury.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Measuring the change of pulmonary function reserve in relation to the irradiated field, before and after treatment, using quantification software.

  The data will analysed using quantification software

  For the individual patient, the duration of participation is six months.

Interventions

pulmonary perfusion/reserve with Tc-99m-MAA SPECT/ Low dose CT RADIATION

1. Patient referred to radiotherapy treatment are evaluated with a baseline PFT \[Forced expiratory volume in 1 second (FEV1), Forced vital capacity (FVC), diffusing capacity of the lung for carbon monoxide (DLCO), Alveolar gas volume (VA)\]. 2. RT simulation at the radiotherapy department and treatment planning. 3. Baseline evaluation of pulmonary perfusion/reserve with Tc-99m-MAA SPECT/ Low dose CT. 4. Radiotherapy.

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients both female and male above 18 years old referred to radiotherapy treatment of primary or secondary malignant involvement of the lung parenchyma.

You may not qualify if:

• Patients undergoing treatments that might induce lung toxicity other than the RT being assessed will be excluded.
• Patients suffering of lung illnesses as infection, pulmonary embolism, and congestive heart failure will be excluded.
• Special populations like pregnant women, children and legally incompetent patients will not be included in this study.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2017
• First Posted: April 21, 2017
• Study Start: May 10, 2017
• Primary Completion: April 2, 2019
• Study Completion: April 2, 2020
• Last Updated: May 2, 2017

Record last verified: 2017-04