Esophageal CancerSPY Q-ICG PASNCT05489757
Quantitative Fluorescence Angiography With ICG for Perfusion Assessment During Surgery
A study testing SPY Portable Handheld Imaging (SPY-PHI) System with SPY-QP Software in people with Esophageal Cancer and Colorectal (Colon or Rectal) Cancer, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
The accurate assessment of intraoperative tissue perfusion is essential in any branch of surgery. Anastomotic leakage (AL) is one of the most feared complications following gastrointestinal surgery, with potentially threatening consequences resulting in worsened short- and long-term outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Colorectal (Colon or Rectal) Cancer
- What is being tested?
- SPY Portable Handheld Imaging (SPY-PHI) System with SPY-QP Software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteItaly
- Study dates
- 16 Feb 2022to 19 May 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participant is willing and able to give informed consent for participation in the trial
- Male and Female, Age > 18 years
- Patients undergoing left colon, rectal or esophagogastric resections
- Patients with malignant or benign disease
- Minimally invasive or open approach surgery
Who cannot join
- Absence of esophagogastric or colorectal reconstruction (e.g. Miles procedure)
- Limited sigmoid resection without ligation of the inferior mesenteric artery
- Known allergies, hypersensitivity or intolerance to indocyanine green (ICG) or iodine contrast agents,
- Patients with hyperthyroidism or benign thyroid tumor
- Acute or chronic kidney failure (stage ≥ 3)
- Pregnant or lactating women, or with a positive pregnancy test performed before surgery
- Any clinical condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SPY Portable Handheld Imaging (SPY-PHI) System With SPY-QP Software for Quantitative Fluorescence Angiography With IndoCyanine Green for Perfusion Assessment During Surgery
The accurate assessment of intraoperative tissue perfusion is essential in any branch of surgery. Anastomotic leakage (AL) is one of the most feared complications following gastrointestinal surgery, with potentially threatening consequences resulting in worsened short- and long-term outcomes. Consistently, a recent meta-analysis showed a correlation between AL and shorter disease-free survival in colorectal surgery. Despite its multifactorial origin, AL is highly related to inadequate visceral perfusion. Traditionally, perfusion assessment and subsequent anastomotic viability have been evaluated by surgeons using intraoperative indicators, such as color, pulsation of vessels, presence of peristalsis and bleeding from the resection lines. However, these clinical parameters are not able to reliably assess the real visceral perfusion and their evaluation is limited in minimally invasive surgery. Hence, the growing interest for innovative techniques able to properly assess tissue perfusion. Among these, the fluorescence angiography (FA) with indocyanine green (ICG) has become increasingly popular during the last decade, although its approval for biomedical purposes by the Food and Drug Administration (FDA) dates back to 1956. ICG is an amphiphilic, non-toxic, tricarbocyanine iodide dye that can be safely injected intravenously and is exclusively eliminated by the liver, without any absorption. Thanks to its fluorescent properties, it allows the real-time visualization of tissue vascularization. FA with ICG has shown promising results for the evaluation of perfusion in numerous surgical procedures, thus leading to modifications of the surgical strategy and consequently to a decrease in the rates of AL. On the other hand, ICG interpretation is subjective, based on the evaluation of fluorescence performed by the operating surgeon. These results lack into a high inter-observer variability and affect the possibility to obtain objective, reproducible and reliable tissue perfusion assessments.
Quantitative fluorescence angiography with ICG (Q-ICG) could overcome these limitations. In Q-ICG the fluorescence signal is elaborated by a new computer quantification algorithm and translated into a fluorescence-time curve (FTC), from which several Q-ICG parameters and values can be extracted. Given the power of ICG in reflecting the perfusion of examined tissues, a new quantification algorithm has the potential to turn the subjective parameters derived from surgeon's perspective into objective numeric values.
Read more
The primary aim of this study is to evaluate which Q-ICG values provided by a new quantification algorithm correspond to subjective perfusion parameters usually evaluated by the surgeon in patients undergoing left colon, rectal or esophagogastric resections.
The secondary aim is to evaluate possible correlations between Q-ICG values provided by the quantification algorithm and perioperative outcomes.
Read the detailed description
The study is designed as a prospective, observational, monocentric, cohort study on algorithm. At our Institution ICG is already used routinely to assess visceral perfusion during gastrointestinal operations. We plan to enroll 70 patients for esophagogastric resections and 140 patients for colorectal resections. Firstly, the adequacy of colon or gastric perfusion will be assessed by the surgical team in the traditional way. Color, pulsatile flow of vessels (right gastroepiploic arcade for the gastric conduit, marginal artery for the colon), presence of peristalsis and bleeding from the colic resection lines will be considered as parameters of perfusion. Then, ICG will be injected, Q-ICG analysis will be performed in all the patients by using a new quantification algorithm and data will be recorded and reported in a specific Database. The surgical strategy will not be modified based on Q-ICG results.
- Being tested
- SPY Portable Handheld Imaging (SPY-PHI) System with SPY-QP Software
- Keywords
- ICG quantification, Esophagectomy, Colorectal resection, Perfusion assessment
- Medical subject headings
- Esophageal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPY Portable Handheld Imaging (SPY-PHI) System with SPY-QP SoftwareDevice
Perfusion assessment with SPY Q-ICG system
| Study group | Role | What they receive |
|---|---|---|
| Perfusion assessment with SPY Q-ICG system | Experimental | Device: SPY Portable Handheld Imaging (SPY-PHI) System with SPY-QP Software Description: Perfusion assessment with SPY Q-ICG system Receives: Device: SPY Portable Handheld Imaging (SPY-PHI) System with SPY-QP Software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum intensity of ICG fluorescence
% (absolute value)
Measured: One timepoint: at day 0, after the externalization of colon/stomach, before packing the colorectal/esophagogastric anastomosis.
Time to first ICG fluorescence signal
seconds
Measured: One timepoint: at day 0, after the externalization of colon/stomach, before packing the colorectal/esophagogastric anastomosis.
Time-to-peak
seconds
Measured: One timepoint: at day 0, after the externalization of colon/stomach, before packing the colorectal/esophagogastric anastomosis.
Secondary outcomes (1)
Correlation with postoperative outcomes
The rate of anastomotic leakage in patients who underwent colorectal or esophagogastric resections
Measured: From day 0 to day 30 after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start16 Feb 2022
- Primary completion19 May 2026
- Study completion19 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, Interventional, Monocentric Cohort Study on Medical Device (CE marked, according to indications for use) Prospective, Observational, Monocentric, Pharmacologic Cohort Study
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riccardo Salvatore Rosati, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05489757
- Sponsor's protocol ID
- 154/INT/2021
- Acronym
- SPY Q-ICG PAS
- Status last verified
- Oct 2026
- First submitted
- 24 Jun 2022
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPY Portable Handheld Imaging (SPY-PHI) System With SPY-QP Software for Quantitative Fluorescence Angiography With IndoCyanine Green for Perfusion Assessment During Surgery
- ClinicalTrials.gov ID
- NCT05489757
- Acronym / sponsor ID
- SPY Q-ICG PAS / 154/INT/2021
- Keywords
- ICG quantification, Esophagectomy, Colorectal resection, Perfusion assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 16 Feb 2022 (actual)
- Primary completion
- 19 May 2026 (actual)
- Study completion
- 19 May 2026 (actual)
- First posted
- 5 Aug 2022 (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.
The accurate assessment of intraoperative tissue perfusion is essential in any branch of surgery. Anastomotic leakage (AL) is one of the most feared complications following gastrointestinal surgery, with potentially threatening consequences resulting in worsened short- and long-term outcomes. Consistently, a recent meta-analysis showed a correlation between AL and shorter disease-free survival in colorectal surgery. Despite its multifactorial origin, AL is highly related to inadequate visceral perfusion. Traditionally, perfusion assessment and subsequent anastomotic viability have been evaluated by surgeons using intraoperative indicators, such as color, pulsation of vessels, presence of peristalsis and bleeding from the resection lines. However, these clinical parameters are not able to reliably assess the real visceral perfusion and their evaluation is limited in minimally invasive surgery. Hence, the growing interest for innovative techniques able to properly assess tissue perfusion. Among these, the fluorescence angiography (FA) with indocyanine green (ICG) has become increasingly popular during the last decade, although its approval for biomedical purposes by the Food and Drug Administration (FDA) dates back to 1956. ICG is an amphiphilic, non-toxic, tricarbocyanine iodide dye that can be safely injected intravenously and is exclusively eliminated by the liver, without any absorption. Thanks to its fluorescent properties, it allows the real-time visualization of tissue vascularization. FA with ICG has shown promising results for the evaluation of perfusion in numerous surgical procedures, thus leading to modifications of the surgical strategy and consequently to a decrease in the rates of AL. On the other hand, ICG interpretation is subjective, based on the evaluation of fluorescence performed by the operating surgeon. These results lack into a high inter-observer variability and affect the possibility to obtain objective, reproducible and reliable tissue perfusion assessments.
Quantitative fluorescence angiography with ICG (Q-ICG) could overcome these limitations. In Q-ICG the fluorescence signal is elaborated by a new computer quantification algorithm and translated into a fluorescence-time curve (FTC), from which several Q-ICG parameters and values can be extracted. Given the power of ICG in reflecting the perfusion of examined tissues, a new quantification algorithm has the potential to turn the subjective parameters derived from surgeon's perspective into objective numeric values.
The primary aim of this study is to evaluate which Q-ICG values provided by a new quantification algorithm correspond to subjective perfusion parameters usually evaluated by the surgeon in patients undergoing left colon, rectal or esophagogastric resections.
The secondary aim is to evaluate possible correlations between Q-ICG values provided by the quantification algorithm and perioperative outcomes.
Detailed description
The study is designed as a prospective, observational, monocentric, cohort study on algorithm. At our Institution ICG is already used routinely to assess visceral perfusion during gastrointestinal operations. We plan to enroll 70 patients for esophagogastric resections and 140 patients for colorectal resections. Firstly, the adequacy of colon or gastric perfusion will be assessed by the surgical team in the traditional way. Color, pulsatile flow of vessels (right gastroepiploic arcade for the gastric conduit, marginal artery for the colon), presence of peristalsis and bleeding from the colic resection lines will be considered as parameters of perfusion. Then, ICG will be injected, Q-ICG analysis will be performed in all the patients by using a new quantification algorithm and data will be recorded and reported in a specific Database. The surgical strategy will not be modified based on Q-ICG results.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, Interventional, Monocentric Cohort Study on Medical Device (CE marked, according to indications for use) Prospective, Observational, Monocentric, Pharmacologic Cohort Study
| Arm | Type | Receives |
|---|---|---|
| Perfusion assessment with SPY Q-ICG system | Experimental | Device: SPY Portable Handheld Imaging (SPY-PHI) System with SPY-QP SoftwareDevice: SPY Portable Handheld Imaging (SPY-PHI) System with SPY-QP Software Description: Perfusion assessment with SPY Q-ICG system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The participant is willing and able to give informed consent for participation in the trial
- Male and Female, Age > 18 years
- Patients undergoing left colon, rectal or esophagogastric resections
- Patients with malignant or benign disease
- Minimally invasive or open approach surgery
Key exclusion criteria (7 listed)
- Absence of esophagogastric or colorectal reconstruction (e.g. Miles procedure)
- Limited sigmoid resection without ligation of the inferior mesenteric artery
- Known allergies, hypersensitivity or intolerance to indocyanine green (ICG) or iodine contrast agents,
- Patients with hyperthyroidism or benign thyroid tumor
- Acute or chronic kidney failure (stage ≥ 3)
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 |
|---|---|---|
| SPY Portable Handheld Imaging (SPY-PHI) System with SPY-QP SoftwarePerfusion assessment with SPY Q-ICG system | Device | Perfusion assessment with SPY Q-ICG system |
Primary outcome
Maximum intensity of ICG fluorescence
Time frame: One timepoint: at day 0, after the externalization of colon/stomach, before packing the colorectal/esophagogastric anastomosis.
% (absolute value)
Time to first ICG fluorescence signal
Time frame: One timepoint: at day 0, after the externalization of colon/stomach, before packing the colorectal/esophagogastric anastomosis.
seconds
Time-to-peak
Time frame: One timepoint: at day 0, after the externalization of colon/stomach, before packing the colorectal/esophagogastric anastomosis.
seconds
1 secondary outcome
Correlation with postoperative outcomes
Time frame: From day 0 to day 30 after discharge
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 27 Oct 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPY Portable Handheld Imaging (SPY-PHI) System with SPY-QP Software in people with Esophageal Cancer and Colorectal (Colon or Rectal) Cancer, run by IRCCS San Raffaele at 1 site in Italy.
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 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: finished, as of the sponsor's last update on 27 Oct 2026. 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 Italy. 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?
Maximum intensity of ICG fluorescence (time frame: One timepoint: at day 0, after the externalization of colon/stomach, before packing the colorectal/esophagogastric anastomosis.). 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 27 Oct 2026.