19F Thoracic Radiotherapy for Lung Cancer

NCT03315065 | Completed Early Phase 1 FDA Drug

• 1 other identifier: Pro00084472
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to determine the feasibility and efficiency of incorporating 19F MR functional lung imaging into the routine assessment of lung cancer patients prior to thoracic radiotherapy.

Conditions

Lung Cancer

Keywords

thoracic Radiation therapy; Lung Function

Outcome Measures

Primary Outcomes (2)

• Number of study patients consented (maximum 8)in order to result in 5 patients successfully completing both 19F functional MR imaging data sets

  4 months

• Proportion of study patients that successfully return for a re-assessment 19F MRI scan after completing radiotherapy.

  6 weeks after completing RT

Study Arms (1)

Patients diagnosed with Lung cancer

OTHER

patients diagnosed with Lung cancer and Thoracic radiotherapy

Drug: Perfluorinated Gas/Oxygen Mixture

Interventions

Perfluorinated Gas/Oxygen Mixture DRUG

19-Fluorine (19F) MRI of the lungs with 21%/79% Oxygen/Perfluorinated Gas, ≤ 25 liters, gas and Mixture of 30% perfluoropropane and 70% oxygen to measure perfusion single visit, \< 1 hour

Also known as: Perfluorinated Propane Imaging

Patients diagnosed with Lung cancer

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has histologic or cytologic confirmation of lung cancer (NSCLC or Small cell) and has been recommended thoracic radiotherapy as part of standard of care management.
• Ability to undergo MR imaging, tolerate breath hold procedures and follow direction during the imaging process
• Karnofsky performance status ≥60, with expected survival of ≥6 months
• At least 18 years of age
• Patient is not pregnant
• Patient can be reliably reached for post-MRI follow up AE check.
• Patient able to sign a study specific informed consent form.

You may not qualify if:

• Any condition including, metallic implants or cardiac pacemakers that makes the candidate ineligible for MR imaging. (MRI research screening form will be completed prior to each MRI scan).
• Malignant pleural effusion or pericardial effusion

Sponsors & Collaborators

• Hal C Charles: lead

Study Sites (1)

Duke University Medical Center - Cancer Center

Durham, North Carolina, 27705, United States

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

• Kolby Sidhu, MD

  Duke University Medical Center, Department of Radiation Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor Radiology

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: October 19, 2017
• Study Start: February 16, 2018
• Primary Completion: June 25, 2019
• Study Completion: June 25, 2019
• Last Updated: July 16, 2019

Record last verified: 2019-07

Locations

US (1)