Lung NeoplasmsPhase 1MIMIGNCT02111824
A Multimodality Image-guided System for Peripheral Lung Cancer Diagnosis and Therapy
A Phase 1 study testing MIMIG System and Indocyanine Green (ICG) in people with Lung Neoplasms and Thoracic Neoplasms, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
The goal of this clinical research study is to test the use of a minimally invasive multimodality image-guided (MIMIG) intervention system used for performing a lung biopsy. The safety of the MIMIG intervention system will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms, Thoracic Neoplasms, Neoplasms by Site
- What is being tested?
- MIMIG System and Indocyanine Green (ICG)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2014to Nov 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (age ≥ 18 years) subjects with peripheral lung lesions that are <1.5 cm in size who are planning to undergo percutaneous image guided lung biopsy as part of their routine medical care.
- 2. Ability to understand and willingness to sign Informed Consent Document (ICD)
Who cannot join
- Age less than 18 years.
- Pregnant or nursing females.
- Known allergy to iodine or intravenous contrast agent.
- Known allergy or anaphylactic reaction to indocyanine green (ICG).
- Patients with renal dysfunction (GFR <60) or patients on dialysis
- Patients with liver dysfunction: total bilirubin > 2.5 mg/dl; albumin < 2.5 mg/dl; alanine aminotransferase (ALT), aspartate aminotransferase (AST) > 5 times upper limits of normal
- Uncorrectable coagulopathy prohibiting biopsy. (INR > 1.5 and/ or platelets < 50,000)
Trial locations and contacts
1 site in 1 country.
United States1 site
MD Anderson Cancer Center Interventional Radiology Dept.
Houston, Texas, 77030
About this study
The goal of this clinical research study is to test the use of a minimally invasive multimodality image-guided (MIMIG) intervention system used for performing a lung biopsy. The safety of the MIMIG intervention system will also be studied.
Read the detailed description
Group 2:
If the patient agrees to take part in this study, the following information about their routine standard of care lung biopsy will be collected:
The accuracy of the procedure How long it takes to complete the procedure How long the needle is inserted to collect the biopsy sample The number of CT scans used during the procedure The radiation dose level used Any complications and/or side effects the patient may experience The results of the diagnosis from the biopsy sample Researchers will take appropriate steps to keep the patient's information private. However, there is no guarantee of absolute privacy. The patient's information will be kept in a password-protected computer at MD Anderson for up to 7 years and will only be permitted to be viewed by the study doctor and members of the research staff.
During the patient's routine lung biopsy, the doctor will use the MIMIG intervention system to help guide the needle for the biopsy the lung biopsy.
Length of Study:
The patient's active participation on this study will be over after the lung biopsy procedure is over.
Description of Procedure:
The first CT scan will be used as a map to guide a needle into the tumor with the MIMIG intervention system. After that, a second CT scan will be done to confirm that the needle tip has been properly inserted inside the lung tumor. Based on the results from these images, the tumor will then be biopsied the same way it would be as part of normal routine care.
This is an investigational study. The use of the MIMIG intervention system to help guide the needle for the lung biopsy is not FDA approved or commercially available. The use of the MIMIG intervention system is investigational.
Up to 24 patients will take part in this study. All will be enrolled at MD Anderson.
Group 3:
If the patient agrees to take part in this study, the following information about the patient's routine standard of care lung biopsy will be collected:
The accuracy of the procedure How long it takes to complete the procedure How long the needle is inserted to collect the biopsy sample The number of CT scans used during the procedure The radiation dose level used Any complications and/or side effects the patient may experience The results of the diagnosis from the biopsy sample Researchers will take appropriate steps to keep the patient's information private. However, there is no guarantee of absolute privacy. The patient's information will be kept in a password-protected computer at MD Anderson and will only be permitted to be viewed by the study doctor and members of the research staff.
During the patient's routine lung biopsy, the doctor will use the MIMIG intervention system to help guide the needle for the biopsy the lung biopsy. The patient will also have an intravenous (IV) needle placed in the patient's vein to give the patient indocyanine green (IC-Green). IC-Green is a dye that allows researchers to see the patient's veins and other organs during the biopsy.
Length of Study:
After the lung biopsy is complete, the patient's active participation on this study will be over.
Description of Procedure:
The first CT scan will be used as a map to guide a needle into the tumor with the MIMIG intervention system. After that, a second CT scan will be done to confirm that the needle tip has been properly inserted inside the lung tumor. A fiberoptic endoscope (a small camera with a light) will be inserted through the CT guided needle to the tumor to help doctors see the tumor blood vessels. IC-Green will also be given by IV to allow doctors to see the blood vessels of the tumor. Based on the results from these images, the tumor will then be biopsied the same way it would be as part of normal routine care.
This is an investigational study. The use of the MIMIG intervention system to help guide the needle for the lung biopsy is not FDA approved or commercially available. The use of the MIMIG intervention system is investigational. The use of fiberoptic endoscope for lung tumor vessels imaging is not FDA approved or commercially available. The use of fiberoptic endoscope is investigational. The use of IC-Green in combination with fiberoptic endoscope for lung tumor vessels imaging is not FDA approved or commercially available. The use of IC-Green in combination with fiberoptic endoscope is investigational.
Up to 24 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Lung Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases
- Being tested
- MIMIG System, Indocyanine Green (ICG)
- Keywords
- Lung Cancer, Peripheral lung lesions, Lung biopsy, Minimally invasive, multimodality image-guided intervention system, MIMIG, Indocyanine green, ICG
- Medical subject headings
- Lung Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIMIG SystemDevice
Also called Dell Workstation T5500, HP Monitor- LP3065, Aurora Field Generator- A4-00207, Aurora System Control Unit- F4-00275
Minimally Invasive MultiModality Imaging Guidance System (MIMIG)
Indocyanine Green (ICG)Drug
Also called indocyanine green (IC-Green)., 3 mg/kg by vein before lung biopsy., Indocyanine green, IC-Green
Use of ICG as staining for fiberoptic visualization of lung tissue via introducer needle prior to obtaining tissue samples.
| Study group | Role | What they receive |
|---|---|---|
| Group 2 | Experimental | During standard of care lung biopsy, the doctor will use the MIMIG system to help guide the needle for the the lung biopsy. Receives: Device: MIMIG System |
| Group 3 | Experimental | During standard of care lung biopsy, the doctor will use the MIMIG system to help guide the needle for the lung biopsy. An intravenous (IV) needle placed in the vein to give indocyanine green (IC-Green). Fiber Optic camera will be used to view tissue before biopsy via insertion catheter. Receives: Device: MIMIG System; Drug: Indocyanine Green (ICG) |
| Group 1 | No intervention | Control Group consists of twelve patients who have undergone biopsy of a peripheral lung lesion by using repetitive CT-guidance. Review of medical records only, no further intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success Rate of Biopsy Using the MIMIG system With + Without Fiber-Optical Imaging
Technical success rate of completing the biopsy procedure using the MIMIG system with and without fiber-optical imaging measured where technical success is defined as the ability to use the navigational components of the MIMIG system to obtain a tissue specimen from a lung nodule; ability to use the navigational components of the system during the biopsy procedure, the ability to successfully perform optical imaging of the lung nodule and the ability to obtain a tissue specimen from the lung nodule.
Measured: 3 Mos
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study start5 Jan 2014
- Primary completionNov 2019
- Study completionNov 2019
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung 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 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- M.D. Anderson Cancer Center
- Responsible party
- Principal investigator, Stephen T. Wong, PhD, The Methodist Hospital Research Institute
- Investigators
- Alda Tam, MD, Principal investigator, MD Anderson Cancer Center Interventional Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111824
- Sponsor's protocol ID
- Pro00009873
- Acronym
- MIMIG
- Status last verified
- Sep 2021
- First submitted
- 9 Apr 2014
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multimodality Image-guided System for Peripheral Lung Cancer Diagnosis and Therapy
- ClinicalTrials.gov ID
- NCT02111824
- Acronym / sponsor ID
- MIMIG / Pro00009873
- Conditions
- Lung Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases
- Keywords
- Lung Cancer, Peripheral lung lesions, Lung biopsy, Minimally invasive, multimodality image-guided intervention system, MIMIG, Indocyanine green, ICG
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Collaborators
- M.D. Anderson Cancer Center
- Study start
- 5 Jan 2014 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 11 Apr 2014 (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.
The goal of this clinical research study is to test the use of a minimally invasive multimodality image-guided (MIMIG) intervention system used for performing a lung biopsy. The safety of the MIMIG intervention system will also be studied.
Detailed description
Group 2:
If the patient agrees to take part in this study, the following information about their routine standard of care lung biopsy will be collected:
The accuracy of the procedure How long it takes to complete the procedure How long the needle is inserted to collect the biopsy sample The number of CT scans used during the procedure The radiation dose level used Any complications and/or side effects the patient may experience The results of the diagnosis from the biopsy sample Researchers will take appropriate steps to keep the patient's information private. However, there is no guarantee of absolute privacy. The patient's information will be kept in a password-protected computer at MD Anderson for up to 7 years and will only be permitted to be viewed by the study doctor and members of the research staff.
During the patient's routine lung biopsy, the doctor will use the MIMIG intervention system to help guide the needle for the biopsy the lung biopsy.
Length of Study:
The patient's active participation on this study will be over after the lung biopsy procedure is over.
Description of Procedure:
The first CT scan will be used as a map to guide a needle into the tumor with the MIMIG intervention system. After that, a second CT scan will be done to confirm that the needle tip has been properly inserted inside the lung tumor. Based on the results from these images, the tumor will then be biopsied the same way it would be as part of normal routine care.
This is an investigational study. The use of the MIMIG intervention system to help guide the needle for the lung biopsy is not FDA approved or commercially available. The use of the MIMIG intervention system is investigational.
Up to 24 patients will take part in this study. All will be enrolled at MD Anderson.
Group 3:
If the patient agrees to take part in this study, the following information about the patient's routine standard of care lung biopsy will be collected:
The accuracy of the procedure How long it takes to complete the procedure How long the needle is inserted to collect the biopsy sample The number of CT scans used during the procedure The radiation dose level used Any complications and/or side effects the patient may experience The results of the diagnosis from the biopsy sample Researchers will take appropriate steps to keep the patient's information private. However, there is no guarantee of absolute privacy. The patient's information will be kept in a password-protected computer at MD Anderson and will only be permitted to be viewed by the study doctor and members of the research staff.
During the patient's routine lung biopsy, the doctor will use the MIMIG intervention system to help guide the needle for the biopsy the lung biopsy. The patient will also have an intravenous (IV) needle placed in the patient's vein to give the patient indocyanine green (IC-Green). IC-Green is a dye that allows researchers to see the patient's veins and other organs during the biopsy.
Length of Study:
After the lung biopsy is complete, the patient's active participation on this study will be over.
Description of Procedure:
The first CT scan will be used as a map to guide a needle into the tumor with the MIMIG intervention system. After that, a second CT scan will be done to confirm that the needle tip has been properly inserted inside the lung tumor. A fiberoptic endoscope (a small camera with a light) will be inserted through the CT guided needle to the tumor to help doctors see the tumor blood vessels. IC-Green will also be given by IV to allow doctors to see the blood vessels of the tumor. Based on the results from these images, the tumor will then be biopsied the same way it would be as part of normal routine care.
This is an investigational study. The use of the MIMIG intervention system to help guide the needle for the lung biopsy is not FDA approved or commercially available. The use of the MIMIG intervention system is investigational. The use of fiberoptic endoscope for lung tumor vessels imaging is not FDA approved or commercially available. The use of fiberoptic endoscope is investigational. The use of IC-Green in combination with fiberoptic endoscope for lung tumor vessels imaging is not FDA approved or commercially available. The use of IC-Green in combination with fiberoptic endoscope is investigational.
Up to 24 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 2 | Experimental | Device: MIMIG SystemDuring standard of care lung biopsy, the doctor will use the MIMIG system to help guide the needle for the the lung biopsy. |
| Group 3 | Experimental | Device: MIMIG System, Drug: Indocyanine Green (ICG)During standard of care lung biopsy, the doctor will use the MIMIG system to help guide the needle for the lung biopsy. An intravenous (IV) needle placed in the vein to give indocyanine green (IC-Green). Fiber Optic camera will be used to view tissue before biopsy via insertion catheter. |
| Group 1 | No intervention | –Control Group consists of twelve patients who have undergone biopsy of a peripheral lung lesion by using repetitive CT-guidance. Review of medical records only, no further intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult (age ≥ 18 years) subjects with peripheral lung lesions that are <1.5 cm in size who are planning to undergo percutaneous image guided lung biopsy as part of their routine medical care.
- 2. Ability to understand and willingness to sign Informed Consent Document (ICD)
Key exclusion criteria (7 listed)
- Age less than 18 years.
- Pregnant or nursing females.
- Known allergy to iodine or intravenous contrast agent.
- Known allergy or anaphylactic reaction to indocyanine green (ICG).
- Patients with renal dysfunction (GFR <60) or patients on dialysis
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 |
|---|---|---|
| MIMIG SystemAlso: Dell Workstation T5500, HP Monitor- LP3065, Aurora Field Generator- A4-00207, Aurora System Control Unit- F4-00275Minimally Invasive MultiModality Imaging Guidance System (MIMIG) | Device | Group 2, Group 3 |
| Indocyanine Green (ICG)Also: indocyanine green (IC-Green)., 3 mg/kg by vein before lung biopsy., Indocyanine green, IC-GreenUse of ICG as staining for fiberoptic visualization of lung tissue via introducer needle prior to obtaining tissue samples. | Drug | Group 3 |
Primary outcome
Technical Success Rate of Biopsy Using the MIMIG system With + Without Fiber-Optical Imaging
Time frame: 3 Mos
Technical success rate of completing the biopsy procedure using the MIMIG system with and without fiber-optical imaging measured where technical success is defined as the ability to use the navigational components of the MIMIG system to obtain a tissue specimen from a lung nodule; ability to use the navigational components of the system during the biopsy procedure, the ability to successfully perform optical imaging of the lung nodule and the ability to obtain a tissue specimen from the lung nodule.
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
- 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.
Alda Tam, MD principal investigator
MD Anderson Cancer Center Interventional Radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MIMIG System and Indocyanine Green (ICG) in people with Lung Neoplasms and Thoracic Neoplasms, run by The Methodist Hospital Research Institute 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 7 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: stopped early, as of the sponsor's last update on 17 Sep 2021. 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?
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 was stopped early (reason given: Slow enrollment). Results are not available in the source record.
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?
Technical Success Rate of Biopsy Using the MIMIG system With + Without Fiber-Optical Imaging (time frame: 3 Mos). 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 17 Sep 2021.