An interventional study of Volumetric MR imaging and Radiation therapy in Malignancy, Metastasis and Hemoptysis, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-10.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment
This proposed study is unique in that patients will not undergo computed tomography (CT) simulation at any point during their treatment course and will instead have same-session magnetic resonance (MR)-only simulation and treatment planning, on-table, using the adaptive radiotherapy (ART) workflow. In this manner, patients requiring urgent treatment could initiate treatment as early as the day of initial radiation oncology consultation.
4,040 studies on the registry are indexed under Neoplasm Metastasis; 886 are open to participants now.
This study's enrollment of 20 is below the median of 50 across 3,268 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
Compared within Neoplasm Metastasis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* All patients will undergo volumetric MR imaging on treatment days in positioning appropriate for the specific treatment site. * Patients will receive standard of care palliative radiation therapy
Device: Volumetric MR imaging · Radiation: Radiation therapy
This will most frequently be supine with arms positioned so not in the way of treatment beams.
-Standard of care
Feasibility of Same-session MRI-only Simulation as Defined as More Than 70% of Patients Receiving at Least 70% of Their Scheduled Treatment Fractions on the First On-table Attempt for Each Respective Fraction.
Time frame: Completion of enrollment (approximately 29 months)
| Milestone | Volumetric MR Imaging Planning |
|---|---|
| Started | 20 |
| Completed | 16 |
| Not completed | 4 |
| Withdrew: Death | 1 |
| Withdrew: Previously unidentified metal artifact | 1 |
| Withdrew: Unable to tolerate lying flat on mr table | 1 |
| Withdrew: Withdrawal by subject | 1 |
| Participants | Volumetric MR Imaging Planning |
|---|---|
| Feasibility of Same-session MRI-only Simulation as Defined as More Than 70% of Patients Receiving at Least 70% of Their Scheduled Treatment Fractions on the First On-table Attempt for Each Respective Fraction. | 16 |
Collected over Adverse events and all-cause mortality were tracked through 1 week following the last day of MRgRT, an average of 2 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Volumetric MR Imaging Planning | 1/16 (6.3%) | 2/16 (12.5%) | 6/16 (37.5%) |
| Event | Volumetric MR Imaging Planning |
|---|---|
| Abdominal painGastrointestinal disorders | 1/16 |
| ConstipationGastrointestinal disorders | 1/16 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/16 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 1/16 |
| Death due to diseaseNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/16 |
| Event | Volumetric MR Imaging Planning |
|---|---|
| Back painMusculoskeletal and connective tissue disorders | 2/16 |
| Abdominal painGastrointestinal disorders | 1/16 |
| DiarrheaGastrointestinal disorders | 1/16 |
| Non-cardiac chest painGeneral disorders | 1/16 |
| AnorexiaMetabolism and nutrition disorders | 1/16 |
| MyalgiaMusculoskeletal and connective tissue disorders | 1/16 |
| FatigueGeneral disorders | 1/16 |
| NauseaGastrointestinal disorders | 1/16 |
| Age, Continuous(years) | Volumetric MR Imaging Planning |
|---|---|
| Median | 66 (28 to 90) |
| Sex: Female, Male(Participants) | Volumetric MR Imaging Planning |
|---|---|
| Female | 12 |
| Male | 8 |
| Ethnicity (NIH/OMB)(Participants) | Volumetric MR Imaging Planning |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 20 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Volumetric MR Imaging Planning |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 16 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Volumetric MR Imaging Planning |
|---|---|
| United States | 20 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices). Participants who opted out of data sharing in the informed consent will not be included.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Beginning 3 months and ending 5 years following article publication
Access criteria: Researches must provide a methodologically sound proposal. Proposals should be directed to kim.hyun@wustl.edu. To gain access, data requestors will need to sign a data access agreement and provide proof of appropriate regulatory approvals as necessary.
Ran from Apr 2019 to primary completion in Jan 2022, 32 months.
Results were first posted in Jan 2023, 1 year after primary completion.
Of 291 non-industry interventional studies with no phase under Neoplasm Metastasis, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 93. This study's 32 months is below that.
Counting every sponsor, half of 316 studies reached it within 54 months; a quarter within 28 and three quarters within 91.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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