Investigating the Feasibility of Using Rapid Cine-MRI for Monitoring Moving and Deforming Tumors

Study ID
STU 042011-034

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

  • Zale Lipshy University Hospital

Contact
Safee Ahmed
214/645-2250
Safee.Ahmed@UTSouthwestern.edu

Principal Investigator
Amit Sawant

Summary

STuDY DeSiGn
Rapid MRi scans from patients with primary non-small-cell lung cancer (nSCLC) patients will be acquired. MR acquisition will be performed without extrinsically administered contrast, using a balanced turbo field echo (TFe) sequence and commercially available coils.

HYPoTHeSiS
1. Rapid cine MR sequences, optimized for [Quote]guidance-quality[Quote] imaging, will enable long-term, non-invasive spatio-temporal monitoring of the entire irradiated thoracic volume.
2. MRi-based 4D monitoring will lead to significant improvements in radiotherapy planning and delivery for lung cancer radiotherapy.

enDPoinT
High-quality 2D and 3D cine MRi time-series depicting complex spatial and temporal evolution of lung tumors and surrounding anatomy.

RaTionaLe:
Current techniques such as 4DCT are inadequate for monitoring respiratory motion as they use a snapshot of a single respiratory cycle to represent all respiratory motion. Consequently, important clinical decisions such as radiotherapy treatment planning and delivery are made based on poor-quality information. Rapid MRi would represent a robust, non-invasive, long term modality that can capture all of the complexities of respiratory motion such as translation, rotation and deformation of tumor target(s) and critical structures within the irradiated volume.

STuDY PHaSe
Pilot

SaMPLe SiZe
10 healthy volunteers: 1volunteer/month
40 patients: 2 patients/month

SCan TiMe
60 minutes per subject including setup, scan and teardown

STuDY ViSiTS
one to two scans will be acquired from each patient. The scans may be acquired prior to and/or during the course of radiotherapy.

SuBJeCT eLiGiBiLiTY CRiTeRia
1. adult subjects ([GreaterThanorequalTo] 18 yrs).
2. (For patients) Confirmed diagnosis of primary or metastatic lung lesion (stages i x iV).
3. able to provide informed consent.
4. able to undergo MRi scan

iMaGinG PRoCeDuRe
Healthy human volunteers and human patients with non-small-cell lung cancer (nSCLC) or metastatic lung lesions will be scanned on a Philips 3.0 or 1.5 T scanner using commercially available coils. each subject will be screened for inclusion/exclusion criteria (Sec 3.1 and 3.2). Patients will be scanned prior to and/or during the course of radiotherapy. Prior to the scan, informed consent will be obtained from each patient. The patient will be asked to read and sign an informed consent form. a verbal explanation of the procedure will also be given to the subject. each subject will be requested to remove all metallic objects from their person, including keys, jewelery, hair pins, pocket knives, watches etc. objects that may be damaged due to the magnetic field, e.g., credit cards, hearing aids, will also need to be removed. The subject will be offered ear plugs to reduce audible noise during the MR imaging procedure.
The imaging procedure is expected to last approximately 45 minutes (30 minutes scanner time) and will consist of real-time MRi scans of the lung while the patient is breathing freely. in addition, two breath-hold scans will also be acquired to serve as controls. The duration of the each breath-hold will be ~10 seconds which we predict to be feasible even in patients with severe lung disease. Continuous audiovisual contact will be maintained with the subject during scanning. each individual will be informed that they can stop the procedure at any point.

Healthy human subjects will be recruited from employees (faculty, students and staff) within the Department of Radiation oncology. informed consent will be obtained by the study coordinator or the principal investigator. Healthy subjects will be recruited during department meetings. uTSW employees will be assured that their decision to participate is entirely voluntary. Their decision and their participation will be kept confidential and will not impact their employment or performance review at uTSW.


Participant Eligibility

3.1.1. Eligible disease(s)/stage(s) [?] AJCC Stage I, II, III or IV non-small-cell lung cancer as well as distant metastasis within the lung to be treated using radiotherapy will be eligible for this study.

3.1.2. Allowable type and amount of prior therapy [?] Any types and amounts of prior therapy will be allowed for this study.

3.1.3. Age restriction and/or gender/ethnic restrictions [?] Subjects must be greater than or equal to 18 years of age. There are no gender or ethnic restrictions.

3.1.4. Life expectancy restrictions [?] None.

3.1.5. ECOG Performance Status [?] ECOG performance status of 3 or less.

3.1.6. Requirements for organ and marrow function [?] None.

3.1.7. Ability to understand and the willingness to sign a written informed consent document.

3.1.8. Able to tolerate supine position

3.1.9. For healthy volunteers - age greater than or equal to 18, ability to understand and the willingness to sign a written informed consent document. and able to tolerate supine position.