Perfusion CT Imaging in Lung Cancer With SBRT

NCT02755454 | Completed

• 1 other identifier: 12-5386-CE
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to determine specific perfusion patterns for radiation induced lung changes and residual/recurrent lung malignancies in patients treated with stereotactic body radiotherapy SBRT and thus improve to distinguish radiation changes from residual/recurrent lung cancers. Currently CT is often unable to make a clear differentiation between benign and malignant changes in the lung after SBRT treatment necessitating additional wait time to perform follow up CTs or biopsies. Optimal treatment may be delayed. The investigators want to apply a CT perfusion sequence in addition to the routine follow up CTs with the goal to obtain perfusion values of post treatment lung changes and lung tumours. The investigators' hypothesis is that CT perfusion values will help differentiate benign post radiation changes from residual/recurrent tumour in the lung with higher confidence and may help avoid unnecessary delays in cancer treatment.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Imaging of during and after SBRT treatment for lung malignancies with a combined perfusion and routine CT to assess therapy response of lung cancer and metastases.

  3-6 months

Study Arms (1)

open label

OTHER

Perfusion CT Imaging

Device: Perfusion CT Imaging

Interventions

Perfusion CT Imaging DEVICE

open label

Eligibility Criteria

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

You may qualify if:

• Gender: male or female
• CT ordered for baseline and follow up in patients with lung cancer and lung metastases treated with
• Patient will sign a consent form prior to study entry
• Lung cancer and lung metastases are biopsy proven

You may not qualify if:

• Patients who are unable to give valid informed consent
• Patients who are unwilling or unable to undergo a CT exam, including subjects with contra-indications to CT exams or intravenous contrast material administration.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Patrik Rogalla

Toronto, Ontario, M5G 2X9, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Patrik Rogalla, MD

  UHN

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 7, 2016
• First Posted: April 29, 2016
• Study Start: October 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: November 20, 2018
• Last Updated: November 23, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)