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

April 30, 2017 updated by: Tel-Aviv Sourasky Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measuring the change of pulmonary function reserve in relation to the irradiated field, before and after treatment, using quantification software.
Time Frame: For the individual patient, the duration of participation is six months.
The data will analysed using quantification software
For the individual patient, the duration of participation is six months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 10, 2017

Primary Completion (Anticipated)

April 2, 2019

Study Completion (Anticipated)

April 2, 2020

Study Registration Dates

First Submitted

April 2, 2017

First Submitted That Met QC Criteria

April 20, 2017

First Posted (Actual)

April 21, 2017

Study Record Updates

Last Update Posted (Actual)

May 2, 2017

Last Update Submitted That Met QC Criteria

April 30, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TASMC-17-ES-0723-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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