To demonstrate the accuracy of FDG-PET for defining disease activity in relapsed MM patients in comparison to X-ray and somatostatin receptor scintigraph (SRS).
ID
Source
Brief title
Condition
- Haematopoietic neoplasms (excl leukaemias and lymphomas)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- To define the increase of FDG-PET uptake in relapsed MM in comparison to SRS
and X-ray examination.
Secondary outcome
Not applicable
Background summary
Multiple Myeloma (MM) is clonal B cell disorder characterised by a monoclonal
plasma cell population in bone marrow, with bone pain, hypercalceamia, and
kidney dysfunction as clinically presenting symptoms. Post-treatment the X-ray
abnormalities persist and no distinction can be made at an early time point
whether vital tumour cells are still present or whether the skeleton
abnormalities contain normal cells. FDG-PET has been used to study the
metabolic activity of the malignant plasma cells. Several small studies have
demonstrated that osteolytic lesions might be FDG-PET positive due to their
higher metabolic activity. The degree of uptake can be quantified which might
indirectly be an indicator of the malignant character of the plasma cells.
Study objective
To demonstrate the accuracy of FDG-PET for defining disease activity in
relapsed MM patients in comparison to X-ray and somatostatin receptor
scintigraph (SRS).
Study design
Pilot study; Patients with relapsed MM are first seen by their haematologist at
the out-patient clinic for follow-up. In case patients fulfill the inclusion
criteria , they will be referred to the department of Nuclear Medicine and
Molecular Imaging (NMMI) for FDG-PET scanning in conjunction other disease
related parameters.
Study burden and risks
- The radiation dose is 7.6 mSv for a patient weighing 80 kg for the FDG PET.
- To perform a FDG-PET scan.
Hanzeplein 1
9700 RB Groningen
Nederland
Hanzeplein 1
9700 RB Groningen
Nederland
Listed location countries
Age
Inclusion criteria
Relapsed multiple myeloma patients that demonstrate increased disease activity
Exclusion criteria
-Ineligible to perform a scan
-Age <18 years.
-Pregnancy.
-Severe kidney dysfunction; serum-creatinine >=250 µM.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL25318.042.08 |