Cancer
Conditions
Keywords
Anal canal, Brain, Breast, Cervix, Esophagus, Gynecology, Head and Neck, Lung, Pancreas, Primary liver or liver metastases, Prostate cancer, Sarcoma
Brief summary
The purpose of this study is to determine if it would be helpful to use advanced MRI imaging techniques to take additional views of the tumor target for radiation treatment planning or treatment follow-up MRI.
Detailed description
The results of this research project will be used to establish a standard MRI protocol specific to each tumor or disease site. An MRI protocol is a list of MR image types that are acquired for each disease site. These images are used to generate the patient's treatment plan.
Interventions
None listed
Sponsors
Medical College of Wisconsin
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 18 years older of any race or gender with anal canal, brain, breast, cervix, esophagus, gynecology, head and neck, lung, pancreas, primary liver or liver metastases, prostate cancer or sarcoma either undergoing MRI scan for radiation treatment planning or a post treatment MRI * Voluntarily signs an IRB approved consent form
Exclusion criteria
* Inability to obtain informed consent from the patient or their medical power of attorney * Patients who are not undergoing MR for radiation treatment planning * Patients who will not have MRI scans after treatment * Patients with pacemakers or other non-MRI compatible metallic implants * Pregnant women, by self report using a standard MRI questionnaire * Patients who will not receive contrast agent as part of their standard MR, will participate only in the non-contrast portion of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Successfully Contributing MRI Data | up to 4 weeks from imaging | We tested these Advanced MR protocols to evaluate which ones would best visualize the target region. This helped us determine the optimum MR SIM protocols for different sites that became clinical standard. |
Countries
United States
Participant flow
Recruitment details
420 was the initial estimate but 158 subjects was the accrual
Pre-assignment details
158 subjects were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| MRI for Treatment Planning or Follow up MRI for treatment planning for radiation therapy or those who have completed treatment and are receiving follow up care. | 158 |
| Total | 158 |
Baseline characteristics
| Characteristic | MRI for Treatment Planning or Follow up |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 44 Participants |
| Age, Categorical Between 18 and 65 years | 114 Participants |
| Sex: Female, Male Female | 85 Participants |
| Sex: Female, Male Male | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 158 |
| serious Total, serious adverse events | 0 / 158 |
Outcome results
Primary
Number of Participants Successfully Contributing MRI Data
We tested these Advanced MR protocols to evaluate which ones would best visualize the target region. This helped us determine the optimum MR SIM protocols for different sites that became clinical standard.
Time frame: up to 4 weeks from imaging
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MRI for Treatment Planning or Follow up | Number of Participants Successfully Contributing MRI Data | 158 Participants |