Lung Nodule, Breast, Kidney,Parathyroid, Mediastinal, Skin Mass, Soft Tissue, Prostate, Stomach Pleural, Head and Neck, and Are at Risk of RecurrenceNCT02640170
Intraoperative Imaging With ICG Registry
An observational study of Lung Nodule, Breast, Kidney,Parathyroid, Mediastinal, Skin Mass, Soft Tissue, Prostate, Stomach Pleural, Head and Neck, and Are at Risk of Recurrence, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
The purpose of this registry is to monitor the rate of recurrence in patients who undergo cancer surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Nodule, Breast, Kidney,Parathyroid, Mediastinal, Skin Mass, Soft Tissue, Prostate, Stomach Pleural, Head and Neck, and Are at Risk of Recurrence
- What is being tested?
- Registry
- How many people
- 291 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Feb 2020
- How long will I take part?
- 30 Days
- Phase
- Observational
- 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
Study population: Patients with a diagnosis of any resectable solid tumor, including but not limited to lung nodule, breast, kidney,parathyroid, mediastinal, skin mass, soft tissue, prostate, stomach pleural, head and neck, and are at risk of recurrence
Who may be able to join
- Inclkusion Criteria
- Adult patients >= 18 years of age
- Patients presenting with any solid tumor and/or diseased tissue even benign nodules presumed to be resectable and are at risk for recurrence.
- Good operative candidate as determined by the treating physician and/or multidisciplinary team
- Subject capable of giving informed consent and participating in the process of consent.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
The purpose of this registry is to monitor the rate of recurrence in patients who undergo cancer surgery.
Read the detailed description
Our objective is to collect prospective data on cancer subjects who undergo surgery and intraoperative imaging. The registry will include (but not limited to) cancer type, stage, intraoperative challenges to the surgeon, usage and results of intraoperative imaging, and recurrence surveillance.
In this protocol, subjects that receive intraoperative imaging will provide us the opportunity to record what tissues fluoresce in the operating room, and then to identify if these lesions are cancer when the histopathology is performed. Also, we will monitor any side effects or potential toxicities that may occur. This data can then be used to predict if a subject is more likely to develop a local recurrence due to missed cancer cells, metastatic lymph nodes or synchronous lesions.
- Being tested
- Registry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegistryOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects registered
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2015 (estimated)
- Study startJul 2016
- Primary completionFeb 2020
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Nodule, Breast, Kidney,Parathyroid, Mediastinal, Skin Mass, Soft Tissue, Prostate, Stomach Pleural, Head and Neck, and Are at Risk of RecurrenceStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 291 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sunil Singhal, MD, PhD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02640170
- Sponsor's protocol ID
- UPCC 16915
- Status last verified
- Jun 2021
- First submitted
- 22 Dec 2015
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Newton AD, Predina JD, Corbett CJ, Frenzel-Sulyok LG, Xia L, Petersson EJ, Tsourkas A, Nie S, Delikatny EJ, Singhal S. Optimization of Second Window Indocyanine Green for Intraoperative Near-Infrared Imaging of Thoracic Malignancy. J Am Coll Surg. 2019 Feb;228(2):188-197. doi: 10.1016/j.jamcollsurg.2018.11.003. Epub 2018 Nov 22.
PubMed 30471345
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Imaging With ICG Registry
- ClinicalTrials.gov ID
- NCT02640170
- Acronym / sponsor ID
- UPCC 16915
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 28 Dec 2015 (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 purpose of this registry is to monitor the rate of recurrence in patients who undergo cancer surgery.
Detailed description
Our objective is to collect prospective data on cancer subjects who undergo surgery and intraoperative imaging. The registry will include (but not limited to) cancer type, stage, intraoperative challenges to the surgeon, usage and results of intraoperative imaging, and recurrence surveillance.
In this protocol, subjects that receive intraoperative imaging will provide us the opportunity to record what tissues fluoresce in the operating room, and then to identify if these lesions are cancer when the histopathology is performed. Also, we will monitor any side effects or potential toxicities that may occur. This data can then be used to predict if a subject is more likely to develop a local recurrence due to missed cancer cells, metastatic lymph nodes or synchronous lesions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of any resectable solid tumor, including but not limited to lung nodule, breast, kidney,parathyroid, mediastinal, skin mass, soft tissue, prostate, stomach pleural, head and neck, and are at risk of recurrence
Key inclusion criteria (5 listed)
- Inclkusion Criteria
- Adult patients >= 18 years of age
- Patients presenting with any solid tumor and/or diseased tissue even benign nodules presumed to be resectable and are at risk for recurrence.
- Good operative candidate as determined by the treating physician and/or multidisciplinary team
- Subject capable of giving informed consent and participating in the process of consent.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Registry | Other | – |
Primary outcome
Number of subjects registered
Time frame: 2 years
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 24 Jun 2021.
- Derived from this study: PubMed 30471345Newton AD, Predina JD, Corbett CJ, Frenzel-Sulyok LG, Xia L, Petersson EJ, Tsourkas A, Nie S, Delikatny EJ, Singhal S. Optimization of Second Window Indocyanine Green for Intraoperative Near-Infrared Imaging of Thoracic Malignancy. J Am Coll Surg. 2019 Feb;228(2):188-197. doi: 10.1016/j.jamcollsurg.2018.11.003. Epub 2018 Nov 22.
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, MD, PhD principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Nodule, Breast, Kidney,Parathyroid, Mediastinal, Skin Mass, Soft Tissue, Prostate, Stomach Pleural, Head and Neck, and Are at Risk of Recurrence, run by Abramson Cancer Center at Penn Medicine 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 5 inclusion and 0 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 24 Jun 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.
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?
Number of subjects registered (time frame: 2 years). 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 NCT02640170, which also lists 1 linked publication.
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 24 Jun 2021.