Solitary Pulmonary NodulesEarly Phase 1NIFI-ICGNCT02851368
Near Infrared Fluorescence Imaging With Indocyanine Green
A Early Phase 1 study testing near infrared fluorescence imaging (NIFI) and Indocyanine Green in people with Solitary Pulmonary Nodules, run by University of Pittsburgh at 1 site in United States.
Trial summary
This research study will evaluate how Near Infrared Fluorescence imaging (NIFI) with indocyanine green (ICG) contrast dye can assist in the identification and diagnosis of lung nodules during surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solitary Pulmonary Nodules
- What is being tested?
- near infrared fluorescence imaging (NIFI) and Indocyanine Green
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Nov 2017
- Phase
- Early 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be willing to undergo surgical biopsy and/or resection of pulmonary nodule(s).
- Women and men at least 18 years of age
- Subjects must have a CT scan of the chest within 8 weeks of surgery
Who cannot join
- Previous thoracic surgery
- Inoperable tumor/nodule
- Unable to tolerate surgery
- History of allergies to iodides
- Breast feeding
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Cardiothoracic Surgery
Pittsburgh, Pennsylvania, 15232
About this study
Official title: A Pilot Trial of Near Infrared Fluorescence Imaging With Indocyanine Green in the Detection and Diagnosis of Neoplastic Pulmonary Nodules
This research study will evaluate how Near Infrared Fluorescence imaging (NIFI) with indocyanine green (ICG) contrast dye can assist in the identification and diagnosis of lung nodules during surgery. NIFI is an intraoperative imaging technology that utilizes a coupled camera/fluorophore (ICG) system to fluoresce tissues of interest. Intravenous ICG is a fluorophore with a long-standing high safety profile.
Read the detailed description
This research study is a pilot test of the effectiveness of a near infrared fluorescence imaging (NIFI) system in the detection and diagnosis of pulmonary nodules. Patients selected for enrollment in this study will be adults (≥18 years) that have been scheduled for surgical biopsy and/or resection of a primary lung nodule identified by prior imaging. Patients will receive an injection of indocyanine green (ICG) contrast dye one day prior to their surgery. Intraoperatively, the NIFI system will be used to visualize and characterize the fluorescence patterns given off by these lung nodules, as well as look for additional undiagnosed nodules. These nodules will then be resected and receive histological characterization, as per standard of care. The NIFI system will be evaluated for its ability to 1) visualize nodules and their margins 2) differentiate between benign and malignant nodules and 3) identify additional undiagnosed nodules.
- Conditions
- Solitary Pulmonary Nodules
- Being tested
- near infrared fluorescence imaging (NIFI), Indocyanine Green
- Keywords
- Indocyanine Green, Fluorescence Imaging
- Medical subject headings
- Solitary Pulmonary Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
near infrared fluorescence imaging (NIFI)Device
The NIFI system will be evaluated for its ability to 1) visualize nodules and their margins 2) differentiate between benign and malignant nodules and 3) identify additional undiagnosed nodules after receiving an injection of indocyanine green 1 day prior to planned surgery.
Indocyanine GreenDrug
Indocyanine Green will be administered intravenously 1 day prior to NIFI.
| Study group | Role | What they receive |
|---|---|---|
| Near Infrared Fluorescence Imaging with Indocyanine Green | Other | Patients will receive an injection of indocyanine green (ICG) 1 day prior to surgery. Near infrared fluorescence imaging (NIFI) will be used to identify pulmonary nodules during the surgical biopsy and/or resection procedure. Receives: Device: near infrared fluorescence imaging (NIFI); Drug: Indocyanine Green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visibility in situ, white light
Measured: Through study completion, an average of one year
Visibility in situ, fluorescence
Measured: Through study completion, an average of one year
Nodule malignancy
Measured: Through study completion, an average of one year
Secondary outcomes (2)
Visibility ex vivo, white light
Measured: Through study completion, an average of one year
Visibility ex vivo, fluorescence
Measured: Through study completion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solitary Pulmonary NodulesStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inderpal Sarkaria, MD, University of Pittsburgh
- Investigators
- Inderpal Sarkaria, MD, Principal investigator, University of Pittsburgh Medical Center/UPP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02851368
- Sponsor's protocol ID
- UPCI 15-205
- Acronym
- NIFI-ICG
- Status last verified
- Nov 2017
- First submitted
- 5 Jul 2016
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of Near Infrared Fluorescence Imaging With Indocyanine Green in the Detection and Diagnosis of Neoplastic Pulmonary Nodules
- ClinicalTrials.gov ID
- NCT02851368
- Acronym / sponsor ID
- NIFI-ICG / UPCI 15-205
- Conditions
- Solitary Pulmonary Nodules
- Keywords
- Indocyanine Green, Fluorescence Imaging
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 1 Aug 2016 (estimated)
- 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 research study will evaluate how Near Infrared Fluorescence imaging (NIFI) with indocyanine green (ICG) contrast dye can assist in the identification and diagnosis of lung nodules during surgery. NIFI is an intraoperative imaging technology that utilizes a coupled camera/fluorophore (ICG) system to fluoresce tissues of interest. Intravenous ICG is a fluorophore with a long-standing high safety profile.
Detailed description
This research study is a pilot test of the effectiveness of a near infrared fluorescence imaging (NIFI) system in the detection and diagnosis of pulmonary nodules. Patients selected for enrollment in this study will be adults (≥18 years) that have been scheduled for surgical biopsy and/or resection of a primary lung nodule identified by prior imaging. Patients will receive an injection of indocyanine green (ICG) contrast dye one day prior to their surgery. Intraoperatively, the NIFI system will be used to visualize and characterize the fluorescence patterns given off by these lung nodules, as well as look for additional undiagnosed nodules. These nodules will then be resected and receive histological characterization, as per standard of care. The NIFI system will be evaluated for its ability to 1) visualize nodules and their margins 2) differentiate between benign and malignant nodules and 3) identify additional undiagnosed nodules.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Near Infrared Fluorescence Imaging with Indocyanine Green | Other | Device: near infrared fluorescence imaging (NIFI), Drug: Indocyanine GreenPatients will receive an injection of indocyanine green (ICG) 1 day prior to surgery. Near infrared fluorescence imaging (NIFI) will be used to identify pulmonary nodules during the surgical biopsy and/or resection procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects must be willing to undergo surgical biopsy and/or resection of pulmonary nodule(s).
- Women and men at least 18 years of age
- Subjects must have a CT scan of the chest within 8 weeks of surgery
Key exclusion criteria (6 listed)
- Previous thoracic surgery
- Inoperable tumor/nodule
- Unable to tolerate surgery
- History of allergies to iodides
- Breast feeding
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 |
|---|---|---|
| near infrared fluorescence imaging (NIFI)The NIFI system will be evaluated for its ability to 1) visualize nodules and their margins 2) differentiate between benign and malignant nodules and 3) identify additional undiagnosed nodules after receiving an injection of indocyanine green 1 day prior to planned surgery. | Device | Near Infrared Fluorescence Imaging with Indocyanine Green |
| Indocyanine GreenIndocyanine Green will be administered intravenously 1 day prior to NIFI. | Drug | Near Infrared Fluorescence Imaging with Indocyanine Green |
Primary outcome
Visibility in situ, white light
Time frame: Through study completion, an average of one year
Visibility in situ, fluorescence
Time frame: Through study completion, an average of one year
Nodule malignancy
Time frame: Through study completion, an average of one year
2 secondary outcomes
Visibility ex vivo, white light
Time frame: Through study completion, an average of one year
Visibility ex vivo, fluorescence
Time frame: Through study completion, an average of one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
- 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.
Inderpal Sarkaria, MD principal investigator
University of Pittsburgh Medical Center/UPP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing near infrared fluorescence imaging (NIFI) and Indocyanine Green in people with Solitary Pulmonary Nodules, run by University of Pittsburgh 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 21 Nov 2017. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Visibility in situ, white light (time frame: Through study completion, an average of one year). The study lists 3 primary outcomes in all. 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 21 Nov 2017.