Lung CancerNCT01859338
Soft Tissue Detection on MRI, Cone Beam CT and Fan Beam CT and Integration of Functional MRI
An observational study of Lung Cancer and Prostate Cancer, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This clinical trial studies magnetic resonance imaging (MRI), cone beam computed tomography (CT), and fan beam CT in detecting soft tissue in patients with prostate and lung cancer undergoing radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Prostate Cancer
- What is being tested?
- cone-beam computed tomography, magnetic resonance imaging and computed tomography
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2012to 24 Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are treated in the Massey Cancer Center Radiation Therapy will be recruited for this observational study.
Who may be able to join
- Patients with lung cancer visible on CT who are scheduled to receive radiation treatment to the area of the primary tumor will be eligible for this study - Renal function tests (blood urea nitrogen [BUN], creatinine [Cr], glomerular filtration rate [GFR]) within 30 days of MRI with GFR > 59 mL/min
- All patients must give written informed consent on a form that includes Health Insurance Portability and Accountability Act (HIPAA) authorization; patient therapy will not be directed by enrollment in this study; participation in this study will not preclude patient participation in additional therapy protocols; subjects will all be recruited from patients undergoing radiotherapy at one of the Virginia Commonwealth University (VCU)-affiliated radiotherapy clinics
Who cannot join
- Patients requiring continuous supplemental oxygen
- Patients with metal implants including pace makers and defibrillators
- Patients with cerebral aneurysm clips or middle ear implant
- Patients with pain pump, a programmable shunt, or non-surgical metal (i.e. a foreign body)
- Claustrophobic patients
- Prior radiotherapy to body area under investigation
- No vulnerable populations will be enrolled (prisoners, children, pregnant females, or institutionalized individuals); women of childbearing potential will undergo a pregnancy test
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
About this study
Official title: Clinical Evaluation of Soft Tissue Detection on MRI, Cone Beam CT and Fan Beam CT and Integration of Functional MR Imaging Into Radiotherapy Planning
This clinical trial studies magnetic resonance imaging (MRI), cone beam computed tomography (CT), and fan beam CT in detecting soft tissue in patients with prostate and lung cancer undergoing radiation therapy. Comparing results of diagnostic procedures done before and during radiation therapy may help doctors predict a patient's response to treatment and help plan the best treatment.
Read the detailed description
PRIMARY OBJECTIVES:
- Establish the technical feasibility of MRI for performing functional soft-tissue targeting of radiotherapy in the pelvis and thorax. (Group I) II. Acquire clinical MR imaging data to evaluate image quality tradeoffs and operational parameter settings. (Group I) III. Validate the selection of MRI technique factors by comparing visibility of soft tissue structures in MRIs, cone beam (CB)CTs and fan beam (FB)CTs of the same patient. (Group II) IV. Assess the feasibility of using deformable image registration to map contours from FBCT to MRI, CBCT to MRI, MRI to MRI and vice versa. (Group II) V. Compare morphologic and functional changes in target and normal structures, visualized on MRI, CBCT and FBCT images, in response to radiation therapy and identify opportunities for treatment adaptation. (Group II)
OUTLINE:
Patients undergo MRI and FBCT at baseline, within the first 3 weeks of radiotherapy and between week 4 and 6 of radiotherapy. Patients with lung cancer may undergo 4 dimensional (4D) CBCT on the same day as the second and third MRI and FBCT.
- Conditions
- Lung Cancer, Prostate Cancer
- Being tested
- cone-beam computed tomography, magnetic resonance imaging, computed tomography
- Medical subject headings
- Lung Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cone-beam computed tomographyRadiation
Also called CBCT
Undergo CBCT
magnetic resonance imagingRadiation
Also called MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Undergo MRI
computed tomographyRadiation
Also called tomography, computed
Undergo fan beam computed tomography
| Study group | Role | What they receive |
|---|---|---|
| MRI, CBCT, FBCT | Patients undergo MRI and fan beam CT (FBCT) at baseline, within the first 3 weeks of radiotherapy and between week 4 and 6 of radiotherapy. Patients with lung cancer may undergo 4D cone beam x-ray CT (CBCT) on the same day as the second and third MRI and FBCT. Receives: Radiation: cone-beam computed tomography; Radiation: magnetic resonance imaging; Radiation: computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical feasibility of MRI for performing functional soft-tissue targeting of radiotherapy in the pelvis and thorax
Make a preliminary comparison of soft tissue structures delineated from MRI to those identified based on cone beam CT (CBCT) and fan beam CT (FBCT). In addition, variations in the soft tissue identification from repeated MR imaging will be compared to morphological imaging.
Measured: up to 6 weeks
Clinical MR imaging data in evaluating image quality tradeoffs and operational parameter settings
Image quality will be assessed by evaluating the utility of various comparative image quality quantifiers such as signal-to-noise ratio (SNR), resolution, and reproducibility of soft-tissue structure identification.
Measured: Up to 6 weeks
Secondary outcomes (3)
Visibility of soft tissue structures in MRIs, CBCTs and FBCTs of the same patient
Compared using a paired t-test.
Measured: Up to 6 weeks
Deformable image registration to map contours from FBCT to MRI, CBCT to MRI, MRI to MRI and vice versa
Compared using a paired t-test.
Measured: Up to 6 weeks
Functional changes in target and normal structures, visualized on MRI, CBCT and FBCT images, in response to radiation therapy and identify opportunities for treatment adaptation
Compared using a paired t-test.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study start6 Mar 2012
- Primary completion18 Jan 2017
- Study completion24 Jan 2017
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabeth Weiss, MD, Principal investigator, Massey Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859338
- Sponsor's protocol ID
- HM13777
- Other IDs
- NCI-2013-00847, MCC-13777
- Status last verified
- Mar 2018
- First submitted
- 7 May 2013
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Soft Tissue Detection on MRI, Cone Beam CT and Fan Beam CT and Integration of Functional MR Imaging Into Radiotherapy Planning
- ClinicalTrials.gov ID
- NCT01859338
- Acronym / sponsor ID
- HM13777
- Conditions
- Lung Cancer, Prostate Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 6 Mar 2012
- Primary completion
- 18 Jan 2017 (actual)
- Study completion
- 24 Jan 2017 (actual)
- First posted
- 21 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial studies magnetic resonance imaging (MRI), cone beam computed tomography (CT), and fan beam CT in detecting soft tissue in patients with prostate and lung cancer undergoing radiation therapy. Comparing results of diagnostic procedures done before and during radiation therapy may help doctors predict a patient's response to treatment and help plan the best treatment.
Detailed description
PRIMARY OBJECTIVES:
- Establish the technical feasibility of MRI for performing functional soft-tissue targeting of radiotherapy in the pelvis and thorax. (Group I) II. Acquire clinical MR imaging data to evaluate image quality tradeoffs and operational parameter settings. (Group I) III. Validate the selection of MRI technique factors by comparing visibility of soft tissue structures in MRIs, cone beam (CB)CTs and fan beam (FB)CTs of the same patient. (Group II) IV. Assess the feasibility of using deformable image registration to map contours from FBCT to MRI, CBCT to MRI, MRI to MRI and vice versa. (Group II) V. Compare morphologic and functional changes in target and normal structures, visualized on MRI, CBCT and FBCT images, in response to radiation therapy and identify opportunities for treatment adaptation. (Group II)
OUTLINE:
Patients undergo MRI and FBCT at baseline, within the first 3 weeks of radiotherapy and between week 4 and 6 of radiotherapy. Patients with lung cancer may undergo 4 dimensional (4D) CBCT on the same day as the second and third MRI and FBCT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI, CBCT, FBCT | – | Radiation: cone-beam computed tomography, Radiation: magnetic resonance imaging, Radiation: computed tomographyPatients undergo MRI and fan beam CT (FBCT) at baseline, within the first 3 weeks of radiotherapy and between week 4 and 6 of radiotherapy. Patients with lung cancer may undergo 4D cone beam x-ray CT (CBCT) on the same day as the second and third MRI and FBCT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are treated in the Massey Cancer Center Radiation Therapy will be recruited for this observational study.
Key inclusion criteria (2 listed)
- Patients with lung cancer visible on CT who are scheduled to receive radiation treatment to the area of the primary tumor will be eligible for this study - Renal function tests (blood urea nitrogen [BUN], creatinine [Cr], glomerular filtration rate [GFR]) within 30 days of MRI with GFR > 59 mL/min
- All patients must give written informed consent on a form that includes Health Insurance Portability and Accountability Act (HIPAA) authorization; patient therapy will not be directed by enrollment in this study; participation in this study will not preclude patient participation in additional therapy protocols; subjects will all be recruited from patients undergoing radiotherapy at one of the Virginia Commonwealth University (VCU)-affiliated radiotherapy clinics
Key exclusion criteria (7 listed)
- Patients requiring continuous supplemental oxygen
- Patients with metal implants including pace makers and defibrillators
- Patients with cerebral aneurysm clips or middle ear implant
- Patients with pain pump, a programmable shunt, or non-surgical metal (i.e. a foreign body)
- Claustrophobic patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cone-beam computed tomographyAlso: CBCTUndergo CBCT | Radiation | MRI, CBCT, FBCT |
| magnetic resonance imagingAlso: MRI, NMR imaging, NMRI, nuclear magnetic resonance imagingUndergo MRI | Radiation | MRI, CBCT, FBCT |
| computed tomographyAlso: tomography, computedUndergo fan beam computed tomography | Radiation | MRI, CBCT, FBCT |
Primary outcome
Technical feasibility of MRI for performing functional soft-tissue targeting of radiotherapy in the pelvis and thorax
Time frame: up to 6 weeks
Make a preliminary comparison of soft tissue structures delineated from MRI to those identified based on cone beam CT (CBCT) and fan beam CT (FBCT). In addition, variations in the soft tissue identification from repeated MR imaging will be compared to morphological imaging.
Clinical MR imaging data in evaluating image quality tradeoffs and operational parameter settings
Time frame: Up to 6 weeks
Image quality will be assessed by evaluating the utility of various comparative image quality quantifiers such as signal-to-noise ratio (SNR), resolution, and reproducibility of soft-tissue structure identification.
3 secondary outcomes
Visibility of soft tissue structures in MRIs, CBCTs and FBCTs of the same patient
Time frame: Up to 6 weeks
Deformable image registration to map contours from FBCT to MRI, CBCT to MRI, MRI to MRI and vice versa
Time frame: Up to 6 weeks
Functional changes in target and normal structures, visualized on MRI, CBCT and FBCT images, in response to radiation therapy and identify opportunities for treatment adaptation
Time frame: Up to 6 weeks
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Weiss, MD principal investigator
Massey Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Prostate Cancer, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical feasibility of MRI for performing functional soft-tissue targeting of radiotherapy in the pelvis and thorax (time frame: up to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2018.