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New treatment option for Aspergillos
Official title Assessment of [18F]-Fluorocellobiose ([18F]FCB) Pharmacokinetics in Healthy Volunteers and Subjects With Invasive Mold Infections
ClinicalTrials.gov ID: NCT07704333
What this study is testing
What is [18F]-Fluorocellobiose ([18F]FCB)?
[18F]-Fluorocellobiose ([18F]FCB) is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for aspergillos.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Background: Fungal infections can cause serious disease in the lungs and other parts of the body. About 3.8 million people die with fungal infections each year.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100. Healthy volunteers may be eligible.
You may be able to join if
- for healthy volunteers (Groups 1 and 2)
- Male or female \>=18 years of age at the time of consent and imaging.
- Provision of signed and dated informed consent form.
- people must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures. Adults...
- Stated willingness to comply with all study procedures and availability for the duration of the study.
You likely can't join if
- Exclusion Criteria for healthy people (Groups 1 and 2) Complete medical records will be reviewed, and within 1-3 months prior to the planned imaging...
- Clinically significant abnormalities on EKG or laboratory testing (blood and urine tests) as judged by the principal investigator.
- Reported pregnancy or pregnancy as determined by positive or indeterminate serum human Chorionic Gonadotrophin (hCG) or urine pregnancy tests prior...
- Lactating females.
- History of uncontrolled diabetes mellitus.
- Lack of adequate venous access.
See the full eligibility criteria
- for healthy volunteers (Groups 1 and 2)
- Male or female \>=18 years of age at the time of consent and imaging.
- Provision of signed and dated informed consent form.
- people must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures. Adults lacking capacity will not be enrolled in this study.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Generally healthy people based on medical history, physical examination, and laboratory testing, as determined by the PI.
- Female participants of childbearing potential must be using a medically acceptable means of contraception. for Patients with PROVEN or PROBABLE Aspergillosis or Mucormycosis Infections (Groups 3a and 3b)
- Male or female \>=18 years of age at the time of consent and imaging.
- Provision of signed and dated informed consent form.
- people must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures. Adults lacking capacity will not be enrolled in this study.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- PROVEN or PROBABLE Invasive fungal disease (IFI), defined by the European Organization for Research and Treatment of Cancer and the Mycoses Study Group Education and Research Consortium (EORTC/MSGERC) [18].
- Female participants of childbearing potential must be using a medically acceptable means of contraception. For inpatients, they should be determined by the attending of record to be stable to participate in the study...
- Male or female \>=18 years of age at the time of consent and imaging.
- Provision of signed and dated informed consent form.
- people must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures. Adults lacking capacity will not be enrolled in this study.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Non-Aspergillus/non-Mucorales mold infections including, but not limited to Cladophialophora spp., Dematiaceous molds (such as Curvularia, Scedosporium spp.) or dimorphic fungi (including, but not limited to Blastomyces...
- Female participants of childbearing potential must be using a medically acceptable means of contraception. For inpatients, they should be determined by the attending of record to be stable to participate in the study...
- Partner vasectomy (making sterile)
- Bilateral tubal ligation
- Intrauterine devices (IUDs)
- Hormonal implants (such as Implanon)
- Other hormonal methods (birth control pills, injections, patches, vaginal rings)
- Exclusion Criteria for healthy people (Groups 1 and 2) Complete medical records will be reviewed, and within 1-3 months prior to the planned imaging, a complete blood count with differential and blood comprehensive...
- Clinically significant abnormalities on EKG or laboratory testing (blood and urine tests) as judged by the principal investigator.
- Reported pregnancy or pregnancy as determined by positive or indeterminate serum human Chorionic Gonadotrophin (hCG) or urine pregnancy tests prior to radiopharmaceutical dosing.
- Lactating females.
- History of uncontrolled diabetes mellitus.
- Lack of adequate venous access.
- Previous nuclear imaging or therapy administered within 5 physical half-lives of the used radioisotope prior to study enrollment.
- Inability to lie flat on the PET/CT bed for the planned duration of scan, including claustrophobia and weight greater than the maximum for the scanner (500 lbs).
- NIH employee who is a subordinate/relative/co-worker of the investigators. Exclusion Criteria for with PROVEN or PROBABLE Aspergillosis or Mucormycosis infections (Groups 3a and 3b) and non-Aspergillus/non-Mucorales...
- Abnormalities on laboratory testing judged by the principal investigator to affect the reliability or safe performance of the scan.
- Participants with severe hepatic and/or renal failure as determined by the primary clinical team
- Reported pregnancy or pregnancy as determined by positive or indeterminate serum human chorionic gonadotrophin (hCG) or urine pregnancy tests prior to radiopharmaceutical dosing.
- Lactating females.
- History of uncontrolled diabetes mellitus.
- Lack of adequate venous access.
- Previous administration of a radioisotope within 5 physical half-lives prior to study enrollment.
- Inability to lie flat on the PET/CT bed for the planned duration of scan, including claustrophobia and weight greater than the maximum for the scanner (500 lbs).
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.