Clinical trial NCT03146117: PET-DECT for Staging and Imaged Based Radiotherapy Planning in Lung Cancer
Official title: Application of Integrated PET and Dual Energy CT Imaging for Staging and Imaged Based Radiotherapy Treatment Planning in Lung Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: PET CT
Keywords: PET CT
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Siemens Corporation, Corporate Technology
First posted: 2017-05-09
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

To be eligible for the study: (All answers must be "YES" for subject to be eligible.)

1. Subject must have a suspected SCLC or NSCLC.
2. Subject must be 18-90 years of age.
3. Subject must have been referred for a clinically indicated PET-CT.
4. Subject must provide written informed consent prior to any study-related procedures being performed.
5. Subject must be willing to comply with all clinical study procedures.

Exclusion Criteria:

The presence of the following excludes subjects from the study: (All answers must be "NO" for subject to be eligible.)

1. 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.
2. Subject has impaired renal function (eGFR\<30 mL/min).
3. Subject has an acute psychiatric disorder or is cognitively impaired.
4. Subject is using or is dependent on substances of abuse.
5. Subject is unwilling to comply with the requirements of the protocol.
6. Subject has an allergy against iodinated contrast agents and cannot be premedicated.
7. Subject is in acute unstable condition.

Primary outcomes:
measure: PET-CT accuracy for lung tumor and thoracic adenopathy detection
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Carlo De Cecco, MD PHD
role: PRINCIPAL_INVESTIGATOR
References: