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出境医 / 临床实验 / Fluciclovine PET/CT in Multiple Myeloma Patients (FLUCIPET)
Fluciclovine PET/CT in Multiple Myeloma Patients (FLUCIPET)
Study Description
Brief Summary:
Comparison between image findings at aminoacid PET/CT and FDG PET/CT for myeloma patients
| Condition or disease |
|---|
| Myeloma, Multiple PET-CT |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 10 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | PET i Diagnostikk og Behandlingsrespons av Pasienter Med Myelomatose |
| Actual Study Start Date : | March 1, 2019 |
| Estimated Primary Completion Date : | January 31, 2020 |
| Estimated Study Completion Date : | January 31, 2029 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- Comparing of image findings at PET [ Time Frame: 1 year ]
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Multiple myeloma patients
Criteria
Inclusion Criteria:
- Multiple myeloma patients suitable for ASCT treatment
Exclusion Criteria:
- Patients with contraindications to ASCT treatment
Contacts and Locations
Contacts
| Contact: Mona-Elisabeth Revheim, MD, PhD, MHA | +4790659373 | monar@ous-hf.no |
Locations
| Norway | |
| Oslo University Hosptal | Recruiting |
| Oslo, Norway, 0424 | |
| Principal Investigator: Mona-Elisabeth Revheim, MD | |
Sponsors and Collaborators
Oslo University Hospital
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 27, 2019 | ||||
| First Posted Date | May 29, 2019 | ||||
| Last Update Posted Date | May 30, 2019 | ||||
| Actual Study Start Date | March 1, 2019 | ||||
| Estimated Primary Completion Date | January 31, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Comparing of image findings at PET [ Time Frame: 1 year ] | ||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Fluciclovine PET/CT in Multiple Myeloma Patients | ||||
| Official Title | PET i Diagnostikk og Behandlingsrespons av Pasienter Med Myelomatose | ||||
| Brief Summary | Comparison between image findings at aminoacid PET/CT and FDG PET/CT for myeloma patients | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Multiple myeloma patients | ||||
| Condition |
|
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| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
10 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | January 31, 2029 | ||||
| Estimated Primary Completion Date | January 31, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
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| Listed Location Countries | Norway | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03966443 | ||||
| Other Study ID Numbers | 2018/2212/REK | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Mona-Elisabeth Revheim, Oslo University Hospital | ||||
| Study Sponsor | Oslo University Hospital | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Oslo University Hospital | ||||
| Verification Date | May 2019 | ||||
