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Imageguided Theranostics in Multiple Myeloma

Imageguided Theranostics in Multiple Myeloma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02403102
Acronym
iTIMM
Enrollment
61
Registered
2015-03-31
Start date
2015-03-26
Completion date
2021-02-28
Last updated
2022-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Myeloma

Keywords

Magnetic Resonance Imaging, Myeloma, Autograft

Brief summary

Theranostics is the use of a diagnostic test to decide which patients will benefit from a certain treatment. The current standard treatment for patients with myeloma is induction chemotherapy followed by peripheral stem cell transplant. Although there are options for timing of treatments, patient outcomes are variable and the investigators do not currently know which patients benefit from which treatment schedule. There is evidence to suggest that residual disease on imaging after treatment is an indicator for a worse prognosis, however the best time point for this imaging is currently not known. This study is designed to show if there is an optimum time point for correlation between imaging and prognosis. Several studies have indicated that MRI is better at detecting disease than FDG PET/CT and the investigators will confirm this when patients are first diagnosed, by performing both FDG PET/CT and whole body diffusion weighted MRI. Patients will then be followed up with whole body diffusion weighted MRI after induction chemotherapy and 3 months post autograft. The investigators will look at the amount of disease present on these scans and correlate this with outcomes. There are likely to be other factors which influence patient outcomes (such as genetics) and the investigators will also look at some of these. Patients who undergo autograft have regular blood tests and marrow samples taken as part of routine care, the investigators will use some of these samples (without compromising the patients treatment) to analyses some of these other factors. If the investigators are able to determine a correlation of genetic factors with outcome this information could be used in future research. Theranostics is the use of a diagnostic test to decide which patients will benefit from a certain treatment. The current standard treatment for patients with myeloma is induction chemotherapy followed by peripheral stem cell transplant. Although there are options for timing of treatments, patient outcomes are variable and the investigators do not currently know which patients benefit from which treatment schedule. There is evidence to suggest that residual disease on imaging after treatment is an indicator for a worse prognosis, however the best time point for this imaging is currently not known. This study is designed to show if there is an optimum time point for correlation between imaging and prognosis. Several studies have indicated that MRI is better at detecting disease than FDG PET/CT and the investigators will confirm this when patients are first diagnosed, by performing both FDG PET/CT and whole body diffusion weighted MRI. Patients will then be followed up with whole body diffusion weighted MRI after induction chemotherapy and 3 months post autograft. The investigators will look at the amount of disease present on these scans and correlate this with outcomes. There are likely to be other factors which influence patient outcomes (such as genetics) and the investigators will also look at some of these. Patients who undergo autograft have regular blood tests and marrow samples taken as part of routine care, the investigators will use some of these samples (without compromising the patients treatment) to analyses some of these other factors. If the investigators are able to determine a correlation of genetic factors with outcome this information could be used in future research.

Interventions

None listed

Sponsors

Cancer Research UK
CollaboratorOTHER
National Institute for Health Research, United Kingdom
CollaboratorOTHER_GOV
Royal Marsden NHS Foundation Trust
CollaboratorOTHER
Institute of Cancer Research, United Kingdom
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All patients over the age of 18 with multiple myeloma planned for autograft.

Exclusion criteria

* MRI incompatible metal implants * Claustrophobia * Diagnosis of other malignancy within 5 years.

Design outcomes

Primary

MeasureTime frame
Construct a ROC curve and calculate area under the curve (AUC) to show that the burden of disease at 3 months post autograft (WB-DWI score) is predictive of disease status at 2 years.2 years post autograph

Secondary

MeasureTime frame
Use multivariate/univariate analysis to identify the best single or combination MRI parameter(s) to predict disease status at 2 years2 years post autograph
Identify optimal cut-off point with best sensitivity and specificity to predict disease status at 2 years.2 years post autograph
Calculate PFS for patients grouped by optimal cut-off.2 years post autograph
Overall survival (OS) in patients with residual disease on WB-DWI post induction and 3 months post autograft.2 years post autograph

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 10, 2026