ADDED VALUE OF 18FDG-PET-CT IN THE DIAGNOSIS OF INVASIVE FUNGAL INFECTIONS IN NEUTROPENIC PATIENTS

Phase 2

Completed

• Conditions: Invasive aspergillosis; fungal infection; 10018849; 10017528

• Registration Number: NL-OMON35827
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

Adult patients (age > 18 years) with a hematologic disease who probably or possibly have an IFI. That means:
* Prolonged (or expected prolonged) neutropenia (leukocyte count < 1,0x109 or granulocyte count < 0,5x109, or leukocyte count < 1,5x109 or granulocyte count < 1,0x109 and decreasing due to chemotherapy), and
* Axillary temperature * 38, 5°C, not reacting on treatment with wide-spectrum antibacterial drugs for 72 hours, and
* A positive HR-CT scan, suspect for an IFI and
o A positive galactomannan-test in serum or fluid acquired by BAL, or positive in both materials (N<=6)
o A negative galactomannan-test GM in both serum and BAL fluid (N<=6)

Exclusion Criteria

* Patients with age < 18 years
* Female patients who are pregnant
* Patients with claustrophobia or other reasons that make the scanning impossible, such as unable to lie still, need of oxygen, and so on.
* Patients who are hemodynamically instable
* (Pre)terminal patients for which the investigation is too burdensome
* Patients who may clinically not be able to undergo the study
* Patients without prolonged or expected prolonged immunocompromised condition (less than 14 days)
* Patients without positive signs of IFI on HR-CT

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified