PET/CT and Bacterial/Fungal PCR in High Risk Febrile Neutropenia
NCT ID: NCT03429387
Last Updated: 2022-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
147 participants
INTERVENTIONAL
2018-01-08
2021-01-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
New Diagnostics in Neutropenia
NCT05174546
FDG-Positron Emission Tomography (PET)/CT In the Evaluation of Persistent Febrile Neutropenia in Cancer Patients
NCT00707213
PET Quantitative Assessments of Solid Tumor Response to Immune Checkpoint Blockade Therapy
NCT01666353
PET and/or MRI Scans in Assessing Tumor Response in Patients Receiving Antiangiogenesis Therapy
NCT00019565
3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer
NCT00935090
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
FDG-PET/CT arm
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.
FDG-PET/CT
FDG-PET performed with low dose CT
Conventional CT arm
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.
Conventional CT
HRCT and CT of sinuses +/- other regions as per clinician's discretion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
FDG-PET/CT
FDG-PET performed with low dose CT
Conventional CT
HRCT and CT of sinuses +/- other regions as per clinician's discretion
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* About to have an autologous haematopoietic stem cell transplant, OR
* Commencing induction or consolidation chemotherapy with curative intent for acute myeloid or acute lymphoid leukaemia
Exclusion Criteria
* Allergy to intravenous contrast for CT imaging
* eGFR \<30
* Pregnant
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Melbourne Health
OTHER
Westmead Hospital
UNKNOWN
Victorian Infectious Diseases Reference Laboratory
UNKNOWN
Peter MacCallum Cancer Centre, Australia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Monica Slavin, MBBS, MD
Role: PRINCIPAL_INVESTIGATOR
Peter MacCallum Cancer Centre, Australia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Melbourne Health
Parkville, Victoria, Australia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
17/98
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.