Solid TumorPhase 1818012NCT02280954
Indocyanine Green for Solid Tumors
A Phase 1 study testing Indocyanine Green (ICG) in people with Solid Tumor and Neoplasms, run by University of Pennsylvania at 1 site in United States.
Trial summary
According to the World Health Organization, cancer is a leading cause of death in men and women, accounting for 7.6 million deaths (around 13% of all deaths) in 2008. Surgery remains the best option for patients presenting with operable Stage I or II cancers, however the five year survival rate for these candidates… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Neoplasms
- What is being tested?
- Indocyanine Green (ICG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Feb 2017
- 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 patients over 18 years of age
- Patients presenting with a solid tumor presumed to be resectable cancer and are at risk for local recurrence on pre-operative assessment
- Good operative candidate as determined by the treating physician and multidisciplinary team
- Subject capable of giving informed consent and participating in the process of consent.
Who cannot join
- Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery
- Subjects with a history of iodide allergies
- Vulnerable patient populations
- People who would be easily lost to follow up
- Patients unable to participate in the consent process (children and neonates).
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Pilot and Feasibility Study of Intraoperative Imagery of Solid Tumors With Indocyanine Green
According to the World Health Organization, cancer is a leading cause of death in men and women, accounting for 7.6 million deaths (around 13% of all deaths) in 2008. Surgery remains the best option for patients presenting with operable Stage I or II cancers, however the five year survival rate for these candidates remains at a dismally low. The high rates of recurrence suggest that surgeons are unable to completely detect and remove primary tumor nodules in a satisfactory manner as well as lingering metastases in sentinel lymph nodes. By ensuring a negative margin through near-infrared imagery it would be possible for us to improve the rates of recurrence from patients and thus overall survival.
- Conditions
- Solid Tumor, Neoplasms
- Being tested
- Indocyanine Green (ICG)
- Keywords
- Solid Tumor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine Green (ICG)Drug
Also called ICG
| Study group | Role | What they receive |
|---|---|---|
| ICG injection group | Experimental | This group will receive a single dose of ICG, infused over 40 minutes. During surgery, they will be imaged with a camera and an imaging probe the investigators have developed. Receives: Drug: Indocyanine Green (ICG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ability of the imaging system to detect the expression of the ICG in the nodule/mass (i.e tumor) and discern the uptake of the dye by the tumor.
Measured: Before surgery
Secondary outcomes (1)
The number of participants that will have an adverse reaction to the ICG.
Measured: Day 1-Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2014 (estimated)
- Study startNov 2013
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sunil Singhall, University of Pennsylvania
- Investigators
- Sunil Singhal, M.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02280954
- Sponsor's protocol ID
- 818012
- Other IDs
- 818012 [UPenn IRB Protocol#]
- Acronym
- 818012
- Status last verified
- Mar 2018
- First submitted
- 21 Nov 2013
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Predina JD, Newton AD, Corbett C, Xia L, Shin M, Sulfyok LF, Okusanya OT, Cengel KA, Haas A, Litzky L, Kucharczuk JC, Singhal S. A Clinical Trial of TumorGlow to Identify Residual Disease During Pleurectomy and Decortication. Ann Thorac Surg. 2019 Jan;107(1):224-232. doi: 10.1016/j.athoracsur.2018.06.015. Epub 2018 Jul 17.
PubMed 30028985Lee JYK, Pierce JT, Thawani JP, Zeh R, Nie S, Martinez-Lage M, Singhal S. Near-infrared fluorescent image-guided surgery for intracranial meningioma. J Neurosurg. 2018 Feb;128(2):380-390. doi: 10.3171/2016.10.JNS161636. Epub 2017 Apr 7.
PubMed 28387632
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot and Feasibility Study of Intraoperative Imagery of Solid Tumors With Indocyanine Green
- ClinicalTrials.gov ID
- NCT02280954
- Acronym / sponsor ID
- 818012 / 818012
- Conditions
- Solid Tumor, Neoplasms
- Keywords
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 3 Nov 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.
According to the World Health Organization, cancer is a leading cause of death in men and women, accounting for 7.6 million deaths (around 13% of all deaths) in 2008. Surgery remains the best option for patients presenting with operable Stage I or II cancers, however the five year survival rate for these candidates remains at a dismally low. The high rates of recurrence suggest that surgeons are unable to completely detect and remove primary tumor nodules in a satisfactory manner as well as lingering metastases in sentinel lymph nodes. By ensuring a negative margin through near-infrared imagery it would be possible for us to improve the rates of recurrence from patients and thus overall survival.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICG injection group | Experimental | Drug: Indocyanine Green (ICG)This group will receive a single dose of ICG, infused over 40 minutes. During surgery, they will be imaged with a camera and an imaging probe the investigators have developed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients over 18 years of age
- Patients presenting with a solid tumor presumed to be resectable cancer and are at risk for local recurrence on pre-operative assessment
- Good operative candidate as determined by the treating physician and multidisciplinary team
- Subject capable of giving informed consent and participating in the process of consent.
Key exclusion criteria (5 listed)
- Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery
- Subjects with a history of iodide allergies
- Vulnerable patient populations
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 |
|---|---|---|
| Indocyanine Green (ICG)Also: ICG | Drug | ICG injection group |
Primary outcome
The ability of the imaging system to detect the expression of the ICG in the nodule/mass (i.e tumor) and discern the uptake of the dye by the tumor.
Time frame: Before surgery
1 secondary outcome
The number of participants that will have an adverse reaction to the ICG.
Time frame: Day 1-Day 30
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 20 Mar 2018.
- Derived from this study: PubMed 30028985Predina JD, Newton AD, Corbett C, Xia L, Shin M, Sulfyok LF, Okusanya OT, Cengel KA, Haas A, Litzky L, Kucharczuk JC, Singhal S. A Clinical Trial of TumorGlow to Identify Residual Disease During Pleurectomy and Decortication. Ann Thorac Surg. 2019 Jan;107(1):224-232. doi: 10.1016/j.athoracsur.2018.06.015. Epub 2018 Jul 17.
- Derived from this study: PubMed 28387632Lee JYK, Pierce JT, Thawani JP, Zeh R, Nie S, Martinez-Lage M, Singhal S. Near-infrared fluorescent image-guided surgery for intracranial meningioma. J Neurosurg. 2018 Feb;128(2):380-390. doi: 10.3171/2016.10.JNS161636. Epub 2017 Apr 7.
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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.
Sunil Singhal, M.D. principal investigator
University of Pennsylvania
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 Indocyanine Green (ICG) in people with Solid Tumor and Neoplasms, run by University of Pennsylvania 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 4 inclusion and 5 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 20 Mar 2018. 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 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?
The ability of the imaging system to detect the expression of the ICG in the nodule/mass (i.e tumor) and discern the uptake of the dye by the tumor. (time frame: Before surgery). 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 NCT02280954, which also lists 2 linked publications.
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 20 Mar 2018.