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Prosthesis Related InfectionsPhase 1NCT01337466

Biodistribution and Dosimetry Evaluation of [124I]FIAU

A Phase 1 study testing [124I]FIAU in people with Prosthesis Related Infections, run by BioMed Valley Discoveries, Inc at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This protocol will evaluate the biodistribution and dosimetry of [124I]FIAU in both healthy volunteers and patients with prosthetic joint infections. This pilot study will also investigate the safety and tolerability of [124I]FIAU. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Prosthesis Related Infections
What is being tested?
[124I]FIAU
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
3 sitesUnited States
Study dates
Dec 2010to Mar 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

The following are the main inclusion criteria for all subjects:

  1. Males or females age > 18 years
  2. Informed consent
  3. Subjects with chronic medical conditions such as hypertension and diabetes should be considered stable by the principal investigator
  4. Women should be postmenopausal or surgically sterile
  5. Able to return for all study assessments

In addition, the following main inclusion criteria apply for subjects with suspected prosthetic joint infection:

  1. Operative intervention planned in the 30 days following study enrollment
  2. Prosthetic joint implant in site for more than 3 months prior to enrollment

The following are the main exclusion criteria for all subjects:

  1. Unable to comply with study requirements
  2. Indication in the opinion of the principal investigator for surgery within 48 hours of presentation.
  3. Receipt of any antibiotic therapy in the 2 weeks preceding imaging
  4. Immunosuppression, e.g., human immunodeficiency virus (HIV) infection, s/p organ transplantation, receipt of steroids for > 10 days at > 10 mg of prednisone equivalent daily within the 90 days prior to enrollment
  5. Requirement for any medication that predisposes to lactic acidosis (e.g., metformin, iron, isoniazid and salicylates; see Appendix A)
  6. Requirement for any medication that has potential mitochondrial toxicity, e.g., nucleoside analogues (zidovudine, didanosine, stavudine)
  7. History of an inherited mitochondrial disorder (e.g., Leber's hereditary neuropathy, neuropathy, ataxia, retinitis pigmentosa and ptosis [NARP], myoneurogenic gastrointestinal encephalopathy [MNGIE], myoclonic epilepsy with ragged red fibers [MERFF] and mitochondrial myopathy, encephalomyopathy, lactic acidosis and stroke-like syndrome [MELAS]
  8. Chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
  9. Pre-existing myopathy or neuropathy
  10. Abnormal liver function tests defined as alanine aminotransferase (ALT) > the upper limit of normal (ULN), aspartate aminotransferase (AST) > ULN, gamma glutamyl transferase (GGT) > ULN
  11. Alcohol use > 3 units per day in men or 2 units per day in women or active intravenous drug use
  12. Creatinine clearance < 30 mL/min
  13. Body mass index > 40
  14. Life expectancy < 6 months
  15. Hypersensitivity to iodine

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • North Shore long Island Jewish Medical Center

    Lake Success, New York, 11042

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

Other trials in United States

About this study

Official title: Biodistribution and Dosimetry of [124i]FIAU in Patients With Prosthetic Joint Infection of The Knee or Hip and Healthy Subjects Using PET-CT Scanning

This protocol will evaluate the biodistribution and dosimetry of [124I]FIAU in both healthy volunteers and patients with prosthetic joint infections. This pilot study will also investigate the safety and tolerability of [124I]FIAU.

Being tested
[124I]FIAU
Keywords
Phase I, FIAU, Fialuridine, Biodistribution, Dosimetry, Prosthetic, Joint, Infection, PET-CT
Medical subject headings
Prosthesis-Related Infections, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [124I]FIAURadiation

    Also called Fialuridine

    This is a single dose study of 2 mCi [124I]FIAU in healthy volunteers or subjects with prosthetic joint infection of the knee or hip who will undergo serial PET-CT scanning.

Study groups in NCT01337466
Study groupRoleWhat they receive
[124I]FIAUExperimentalsingle dose study of [124I]FIAU in healthy volunteers or subjects with prosthetic joint infection who will undergo PET-CT scanning
Receives: Radiation: [124I]FIAU

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine the biodistribution and dosimetry evaluation of [124I]FIAU

    Subjects will be dosed with [124I]FIAU at Time 0 on Day 0, and a PET-CT scan will be conducted immediately after the injection. Imaging will be repeated at 2 hours, 4 hours, 6 hours, 24 hours, 48 hours, and 72 hours after dosing.

    All images generated will be reviewed for biodistribution and dosimetry.

    Measured: 72 hrs

Secondary outcomes (1)

  1. Evaluate the safety and tolerability of [124I]FIAU

    Safety will be monitored throughout the study for all subjects. Safety will be assessed by monitoring of adverse events and vital signs, clinical laboratory tests including LFTs, lactate, serum chemistry and CBC, physical examination, and 12-lead ECG.

    Measured: 28 +/- 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2011 (estimated)
  2. Study startDec 2010
  3. Primary completionDec 2012
  4. Study completionMar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01337466
Sponsor's protocol ID
BVD001
Status last verified
Jun 2013
First submitted
8 Apr 2011
Last updated
27 Jun 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [124I]FIAU in people with Prosthesis Related Infections, run by BioMed Valley Discoveries, Inc at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the biodistribution and dosimetry evaluation of [124I]FIAU (time frame: 72 hrs). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01337466.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2013.

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