Head and Neck NeoplasmsNCT03561324
Intraoperative Imaging of a PET Positive Lymph Node(s) Using 18FDG and a Dual-Mode, Hand-Held Intraoperative Imager
A study testing Imaging Beta Probe (IBP) in people with Head and Neck Neoplasms, run by University of Arkansas at 1 site in United States.
Trial summary
This study is a prospective collection of data utilizing the Imaging Beta Probe (IBP) in patients with positron emission tomography (PET) positive disease. A pilot clinical study involving 5 patients will be conducted using the IBP. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Imaging Beta Probe (IBP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2018to 22 Jan 2020
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, 18- to 90-years old.
- Positive for PET positive disease in the neck.
Who cannot join
- Pregnant women (all women of child bearing potential will have undergone pregnancy testing as standard of care)
- Nursing or lactating women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
This study is a prospective collection of data utilizing the Imaging Beta Probe (IBP) in patients with positron emission tomography (PET) positive disease. A pilot clinical study involving 5 patients will be conducted using the IBP. The sterilized IBP will be used intraoperatively in surgical wounds for localization of tumor sites and detecting completeness of excision vs. positive margins. The outcome of each of these studies will be documented and used to demonstrate clinical benefits of the new probe. The investigators will correlate the images from the probe of the Fludeoxyglucose (18FDG) positive tissue, both in-vivo and ex-vivo after dissection, with the previously performed PET scan and with the routine pathology results obtained on the surgical specimens.The experimental imaging modality studied in this protocol will be compared to clinically utilized modalities of ultrasound and PET/ CT. Localization between imaging modalities will be compared with respect to: detection and side of localization.
- Conditions
- Head and Neck Neoplasms
- Being tested
- Imaging Beta Probe (IBP)
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging Beta Probe (IBP)Device
Using IBP for imaging of PET positive lymph nodes
| Study group | Role | What they receive |
|---|---|---|
| Use of IntraOperative Imaging Probe | Experimental | The sterilized (Imaging Beta Probe) IBP will be used intraoperatively in surgical wounds for localization of tumor sites and detecting completeness of excision vs. positive margins. Receives: Device: Imaging Beta Probe (IBP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of PET positive disease
Localization between imaging modalities will be compared with respect to: detection (y/n) and side of localization (r/l).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start20 Jun 2018
- Primary completion22 Jan 2020
- Study completion22 Jan 2020
Why it stopped: PI leaving institution/no funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- Radiation Monitoring Devices, Inc.
- Responsible party
- Sponsor
- Investigators
- Deanne L King, MD, Study director, 501-686-5140
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561324
- Sponsor's protocol ID
- 217729
- Status last verified
- Jan 2020
- First submitted
- 31 May 2018
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Imaging of a PET Positive Lymph Node(s) Using 18FDG and a Dual-Mode, Hand-Held Intraoperative Imager
- ClinicalTrials.gov ID
- NCT03561324
- Acronym / sponsor ID
- 217729
- Conditions
- Head and Neck Neoplasms
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI leaving institution/no funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- Radiation Monitoring Devices, Inc.
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 22 Jan 2020 (actual)
- Study completion
- 22 Jan 2020 (actual)
- First posted
- 19 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective collection of data utilizing the Imaging Beta Probe (IBP) in patients with positron emission tomography (PET) positive disease. A pilot clinical study involving 5 patients will be conducted using the IBP. The sterilized IBP will be used intraoperatively in surgical wounds for localization of tumor sites and detecting completeness of excision vs. positive margins. The outcome of each of these studies will be documented and used to demonstrate clinical benefits of the new probe. The investigators will correlate the images from the probe of the Fludeoxyglucose (18FDG) positive tissue, both in-vivo and ex-vivo after dissection, with the previously performed PET scan and with the routine pathology results obtained on the surgical specimens.The experimental imaging modality studied in this protocol will be compared to clinically utilized modalities of ultrasound and PET/ CT. Localization between imaging modalities will be compared with respect to: detection and side of localization.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of IntraOperative Imaging Probe | Experimental | Device: Imaging Beta Probe (IBP)The sterilized (Imaging Beta Probe) IBP will be used intraoperatively in surgical wounds for localization of tumor sites and detecting completeness of excision vs. positive margins. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women, 18- to 90-years old.
- Positive for PET positive disease in the neck.
Key exclusion criteria (2 listed)
- Pregnant women (all women of child bearing potential will have undergone pregnancy testing as standard of care)
- Nursing or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imaging Beta Probe (IBP)Using IBP for imaging of PET positive lymph nodes | Device | Use of IntraOperative Imaging Probe |
Primary outcome
Detection of PET positive disease
Time frame: Day 1
Localization between imaging modalities will be compared with respect to: detection (y/n) and side of localization (r/l).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deanne L King, MD study director
501-686-5140
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imaging Beta Probe (IBP) in people with Head and Neck Neoplasms, run by University of Arkansas at 1 site 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?
The sponsor lists 2 inclusion and 2 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Detection of PET positive disease (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2020.