PET-DECT for Staging and Imaged Based Radiotherapy Planning in Lung Cancer

NCT03146117 | Terminated DMC

• 1 other identifier: Pro00060975
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this project is to investigate the diagnostic performance of integrated F-18 fluorodeoxyglucose-positron emission tomography (FDG-PET) and Dual Energy CT (DECT) imaging in determining the thoracic nodal status of small-cell lung cancer (SCLC) and non-small-cell lung cancer (NSCLC), and its impact on target volume delineation for image guided radiation therapy (IGRT) planning.

Conditions

PET CT

Keywords

PET CT

Outcome Measures

Primary Outcomes (1)

• PET-CT accuracy for lung tumor and thoracic adenopathy detection

  Knowledge gained during this study may potentially allow for an improvement in PET-CT accuracy for lung tumor and thoracic adenopathy detection, and for a more accurate definition of the RT target, decreasing the radiation dose delivered to normal tissue.

  One year

Eligibility Criteria

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

Study Population

The investigators plan to recruit a total of 50 individuals (male, female; age range 18-90 years) referred to undergo a clinically indicated PET-CT examination. Patients will be identified from the Radiology department schedule. With the proposed 50 patient data set, the investigators are neither targeting nor avoiding the selective recruitment of women and minorities. Given the narrow inclusion criteria, the investigators plan to recruit patients irrespective of demographics. The patient will be approached by IRB-approved study personnel under the direction of one of the licensed physician investigators listed on the study, either prior to or on the day of the planned PET-CT examination (a single study visit, with the objective to perform the clinically indicated imaging), with a full explanation and request for consent as required by the IRB. MUSC policies regarding patient consent will be followed. The study design is not randomized.

You may qualify if:

• To be eligible for the study: (All answers must be "YES" for subject to be eligible.)
• Subject must have a suspected SCLC or NSCLC.
• Subject must be 18-90 years of age.
• Subject must have been referred for a clinically indicated PET-CT.
• Subject must provide written informed consent prior to any study-related procedures being performed.
• Subject must be willing to comply with all clinical study procedures.

You may not qualify if:

• The presence of the following excludes subjects from the study: (All answers must be "NO" for subject to be eligible.)
• Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:
• By testing (serum or urine βHCG) within 24 hours before contrast agent administration, or
• By surgical sterilization, or
• Post-menopausal, with minimum one (1) year history without menses.
• Subject has impaired renal function (eGFR\<30 mL/min).
• Subject has an acute psychiatric disorder or is cognitively impaired.
• Subject is using or is dependent on substances of abuse.
• Subject is unwilling to comply with the requirements of the protocol.
• Subject has an allergy against iodinated contrast agents and cannot be premedicated.
• Subject is in acute unstable condition.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Siemens Corporation, Corporate Technology: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29401, United States

Location

Study Officials

• Carlo De Cecco, MD PHD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 9, 2017
• Study Start: April 1, 2017
• Primary Completion: June 15, 2018
• Study Completion: June 15, 2018
• Last Updated: June 21, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)