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| Name | Class |
|---|---|
| Melbourne Health | OTHER |
| Westmead Hospital | OTHER |
| Victorian Infectious Diseases Reference Laboratory | UNKNOWN |
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Patients with acute leukaemia requiring induction or consolidation chemotherapy and those requiring a haematopoietic stem cell transplant are at high risk of fever and infection when they have low white cell counts (neutropenic fever). The causes of neutropenic fever are frequently unknown and patients are treated with broad antibiotics, without a clear target to what is being treated.
This study will prospectively enroll patients who are receiving chemotherapy for acute leukaemia or for a stem cell transplant and compare the diagnostic utility of bacterial and fungal PCR performed directly off blood drawn, to the standard blood culture. Patients who have persistent fever after 72 hours of antibiotics will then be randomized to have either the interventional scan (PET/CT) or the conventional scan (standard CT) to look for a source of infection. Diagnostic yield, change in management and outcomes will be compared between arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FDG-PET/CT arm | Experimental | Participants with persistent febrile neutropenia after 72 hours of onset who are randomized to this arm will have an FDG-PET/CT performed to look for source of fever. |
|
| Conventional CT arm | Active Comparator | Participants with persistent febrile neutropenia after 72 hours of onset who are randomized to this arm will have a conventional CT (HRCT chest and sinuses +/- other regions as per clinician's discretion) performed to look for source of fever. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FDG-PET/CT | Diagnostic Test | FDG-PET performed with low dose CT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in management following randomized scan | Defined as:
| Within 48 hours of scan result |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with a cause of neutropenic fever | The proportion of participants in each arm where there is a confirmed cause of neutropenic fever | By hospital discharge, an average of 4 weeks |
| Hospital length of stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Monica Slavin, MBBS, MD | Peter MacCallum Cancer Centre, Australia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peter MacCallum Cancer Centre | Melbourne | Victoria | 3000 | Australia | ||
| Melbourne Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38102639 | Derived | Tew M, Douglas AP, Szer J, Bajel A, Harrison SJ, Tio SY, Worth LJ, Hicks RJ, Ritchie D, Slavin MA, Thursky KA, Dalziel K. Evaluating the cost-effectiveness of [18F]FDG-PET/CT for investigation of persistent or recurrent neutropenic fever in high-risk haematology patients. Cancer Imaging. 2023 Dec 15;23(1):119. doi: 10.1186/s40644-023-00647-7. | |
| 35777413 |
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Participants will be randomized to either the PET/CT arm or the conventional CT arm
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| Conventional CT | Diagnostic Test | HRCT and CT of sinuses +/- other regions as per clinician's discretion |
|
The duration (in days) of hospital length of stay for the episode in which neutropenic fever occurred
| By hospital discharge, an average of 4 weeks |
| Costs of hospital care | The overall cost of the inpatient stay for the episode in which neutropenic fever occurred | By hospital discharge, an average of 4 weeks |
| Proportion admitted to intensive care | The proportion of patients in each arm who were admitted to intensive care during their admission in which neutropenic fever occurred | By hospital discharge, an average of 4 weeks |
| In hospital mortality | The proportion of patients per arm who have passed away during the admission in which neutropenic fever occurred | By hospital discharge, an average of 4 weeks |
| 6 month mortality | The proportion of patients per arm who have passed away 6 months post study entry | 6 months from study entry |
| Parkville |
| Victoria |
| 3052 |
| Australia |
| Douglas A, Thursky K, Spelman T, Szer J, Bajel A, Harrison S, Tio SY, Bupha-Intr O, Tew M, Worth L, Teh B, Chee L, Ng A, Carney D, Khot A, Haeusler G, Yong M, Trubiano J, Chen S, Hicks R, Ritchie D, Slavin M. [18F]FDG-PET-CT compared with CT for persistent or recurrent neutropenic fever in high-risk patients (PIPPIN): a multicentre, open-label, phase 3, randomised, controlled trial. Lancet Haematol. 2022 Aug;9(8):e573-e584. doi: 10.1016/S2352-3026(22)00166-1. Epub 2022 Jun 28. |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D064147 | Febrile Neutropenia |
| D004194 | Disease |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009503 | Neutropenia |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D007960 | Leukocyte Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000072078 | Positron Emission Tomography Computed Tomography |
| ID | Term |
|---|---|
| D049268 | Positron-Emission Tomography |
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014057 | Tomography, X-Ray Computed |
| D064847 | Multimodal Imaging |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |
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