Feasibility of CT Perfusion (CTP) as a noninvasive method for characterizing pulmonary lesions as benign or malignant: Comparison of CTP findings with histopathology and other imaging results.

Study ID
STU 122011-106

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

Contact
Shaun Nordeck
214-645-8976
shaun.nordeck@utsouthwestern.edu

Principal Investigator
Cecelia Brewington

Summary

This project will be a nonrandomized prospective study. Broad notification of the study (including participant criteria) to all uT Services and neighboring facilities through electronic and print communications would be conducted to aid in recruitment. Radiology, Primary care, oncology, Pulmonary, and Surgical services would be of primary emphasis. Participants meeting inclusion criteria and consenting to research participation would undergo CT Perfusion of their pulmonary lesion prior to biopsy or surgical resection (ideally within a 30 day timeframe).

Since this study's primary aim is to determine the feasibility of CT perfusion in determining benign versus malignant, a total of 50 patients with pulmonary lesions will be recruited. it is assumed our population base will be disproportionately malignant, between 80-90%, therefore larger studies which include subsets of radiographically benign lesions will needed in the future.

CT Perfusion exams will be performed at Zale Lipshy hospital utilizing the aquillion one CT scanner with perfusion imaging software and low dose technique. CT Perfusion images will be interpreted by a total of 4 board certified radiologists of which 2 will be blinded to the patient's history and prior imaging findings. Perfusion study findings will then be correlation with patient history, demographics, prior studies (PeT, CT, MRi, etc) and final tissue diagnosis. Statistical analysis (likely a multivariate logistic regression) will be performed to identify significance of findings.

Study participants medical charts will be reviewed retrospectively at initial enrollment. Charts will be reviewed to assess CT Perfusion findings against current mainstream imaging (PeT, CT, MRi, etc) and screening techniques, assess outcomes, determine risk/benefit ratio to the patients, as well assess the potential cost benefit of CTP vs traditional care.

Technology to be used during this study is the Toshiba aquilion one 320-detector CT scanner with perfusion imaging software package. additionally the newest version of Toshiba's iterative reconstruction software (aiDR 3D) will be utilized. Contrast enhancement will be achieved within intravenous administration of iopamidol/isovue 370.

as previously stated, 2 of the 4 radiologists interpreting the studies will be blinded to the patient's history, clinical findings, and prior medical imaging. Radiologists will interpret the images as Benign, indeterminate, Malignant, or non-diagnostic. For Benign, indeterminate, or Malignant ratings they will use a 5-point Likert scale of certainty of results.

The primary endpoint is the completion of CT Perfusion of 50 pulmonary lesions with histopathology correlation.

Given this study is aimed at extending previous research, a total of 50 patients will be consented for CT Perfusion imaging.

Participants will have their charts retrospectively reviewed to assess clinical history, laboratory, and imaging findings.

Participant Eligibility

.1 Males or females of age >= 18 years.

.2 Pulmonary lesion (nodule and/or mass) detected during routine medical care (e.g. CT, Chest X-ray, MRI, Nuclear Medicine, etc.) scheduled to undergo biopsy or surgical resection.

.3 Pulmonary Lesion Requirements: A detected lesion (pulmonary nodule or mass) measuring >= 6 mm and <= 30 mm in greatest diameter. Nodules are defined as < 20 mm while masses are defined as >= 20 mm. Lesions must be non-calcified.

.4 Ability to participate cooperatively with the procedures.

.5 Ability to provide consent for procedures (No medical or psychiatric condition precluding informed medical consent).

6 Women of child-bearing potential must complete UTSW pregnancy status questionnaire.

6.1 A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:


* Has not undergone a hysterectomy or bilateral oophorectomy; or

* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).