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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03123679
• Other study ID #: TASMC-17-ES-0723-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: April 2, 2017
• Last updated: April 30, 2017
• Start date: May 10, 2017
• Est. completion date: April 2, 2020

Study information

• Verified date: April 2017
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: April 2, 2020
• Est. primary completion date: April 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Radiation:
• pulmonary perfusion/reserve with Tc-99m-MAA SPECT/ Low dose CT
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)]. RT simulation at the radiotherapy department and treatment planning. Baseline evaluation of pulmonary perfusion/reserve with Tc-99m-MAA SPECT/ Low dose CT. Radiotherapy.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.