Colon CancerICGNCT07638956
ICG in Colon Cancer
A study testing Indocyanine green (ICG) injection for intraoperative lymph node imaging and Laparoscopic Colon Cancer Resection in people with Colon Cancer and ICG (Indocyanine Green), run by Tanta University.
Trial summary
The aim of this study is to evaluate the role of indocyanine green (ICG) injection in fluorescence-guided lymphatic mapping during laparoscopic colon cancer resection. This is a single-center prospective single-arm pilot clinical study that will include at least 25 patients with resectable colon cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, ICG (Indocyanine Green)
- What is being tested?
- Indocyanine green (ICG) injection for intraoperative lymph node imaging and Laparoscopic Colon Cancer Resection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age >= 18 years.
- Histologically confirmed colon adenocarcinoma.
Who cannot join
- Emergency surgery (obstruction/perforation with sepsis) requiring urgent operation.
- Known allergy or contraindication to ICG (including prior anaphylaxis to ICG; severe hypersensitivity history per anesthesia assessment).
- Pregnancy or breastfeeding.
- Severe hepatic failure (because ICG clearance is hepatobiliary) or other contraindication determined by anesthesia team.
- Planned palliative resection only.
- ASA physical status IV or patients otherwise deemed unfit for elective curative colectomy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Study of Indocyanine Green (ICG) Fluorescence-Guided Lymphatic Mapping During Laparoscopic Colon Cancer Resection
The aim of this study is to evaluate the role of indocyanine green (ICG) injection in fluorescence-guided lymphatic mapping during laparoscopic colon cancer resection. This is a single-center prospective single-arm pilot clinical study that will include at least 25 patients with resectable colon cancer. All enrolled patients will undergo intraoperative subserosal ICG-guided lymphatic mapping before dissection, and intravenous ICG perfusion assessment before anastomosis. The primary goal is to determine the proportion of analyzable pN+ patients in whom all metastatic lymph nodes identified on final histopathology are located within the ICG-mapped lymphatic basin.
Read the detailed description
Adequate lymphadenectomy is a key component of curative colon cancer surgery because lymph node status is essential for accurate staging and postoperative treatment planning. Indocyanine green (ICG) fluorescence imaging has become increasingly used intraoperatively to make otherwise invisible lymphatic pathways visible in real time.
Preoperative and Perioperative Care:
All patients will undergo standard preoperative evaluation including colonoscopy with biopsy confirmation, baseline laboratory investigations, carcinoembryonic antigen measurement, and contrast-enhanced CT staging. Perioperative care will follow an enhanced recovery pathway including counseling, thromboembolism prophylaxis, antibiotic prophylaxis, multimodal analgesia, early mobilization, and early oral intake.
Operative Protocol:
Laparoscopic oncologic colectomy will be performed according to tumor location. Fluorescence imaging will be performed using the KARL STORZ IMAGE1 STM Rubina platform. Indocyanine green will be injected subserosally around the tumor in four quadrants whenever feasible. Near-infrared imaging will then be used to identify lymphatic channels and nodal basins before definitive mesenteric division. Any fluorescence-related modification of the extent of mesenteric excision or pedicle clearance will be recorded prospectively. Before bowel anastomosis, intravenous indocyanine green will be used to assess perfusion of the bowel ends by near-infrared fluorescence imaging.
Pathology and Follow-up:
The mapped area will be identified on the specimen by sutures or clips or separately labeled packets, allowing the pathologist to record metastatic lymph nodes as located within or outside the ICG-mapped basin. Patients will be followed during hospital admission and for 3, 6, and 9 months after surgery to record postoperative complications, final histopathological outcomes, and morbidity according to the Clavien-Dindo classification
- Conditions
- Colon Cancer, ICG (Indocyanine Green)
- Being tested
- Indocyanine green (ICG) injection for intraoperative lymph node imaging, Laparoscopic Colon Cancer Resection
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine green (ICG) injection for intraoperative lymph node imagingDrug
Indocyanine green is injected subserosally around the tumor in four quadrants for lymphatic mapping. Additionally, intravenous ICG is administered before bowel anastomosis to assess perfusion of the bowel ends using near-infrared fluorescence imaging.
Laparoscopic Colon Cancer ResectionProcedure or surgery
Standard laparoscopic colectomy with oncologic lymphadenectomy performed according to institutional practice.
| Study group | Role | What they receive |
|---|---|---|
| ICG-Guided Surgery | Experimental | All patients enrolled in this single-arm study will undergo intraoperative subserosal injection of Indocyanine Green (ICG) for fluorescence-guided lymphatic mapping prior to mesenteric dissection. Additionally, an intravenous ICG injection will be administered to assess bowel perfusion before creating the anastomosis during laparoscopic colon cancer resection. Receives: Drug: Indocyanine green (ICG) injection for intraoperative lymph node imaging; Procedure: Laparoscopic Colon Cancer Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of analyzable pN+ patients with all metastatic lymph nodes located within the ICG-mapped lymphatic basin
This outcome evaluates the accuracy of ICG mapping. It is measured as the proportion of analyzable pN+ patients in whom all metastatic lymph nodes identified on final histopathology are located within the ICG-mapped lymphatic basin.
Measured: Up to 2 weeks postoperatively (upon completion of final histopathology report)
Secondary outcomes (6)
Successful intraoperative visualization of lymphatic drainage (Feasibility rate)
The rate of successful intraoperative visualization of lymphatic channels and nodal basins after subserosal ICG injection.
Measured: Intraoperative
Frequency of fluorescence-guided modification of mesenteric excision
The frequency at which ICG mapping prompts a modification in the extent of mesenteric excision or pedicle clearance.
Measured: Intraoperative
Change in the planned transection line due to perfusion assessment
The proportion of cases in which intravenous ICG perfusion assessment leads to a change in the planned bowel transection line.
Measured: Intraoperative
Metastatic lymph nodes identified outside conventional resection margins
The frequency of identifying metastatic lymph nodes located outside the predefined conventional resection margins using ICG guidance.
Measured: Up to 2 weeks postoperatively (upon completion of final histopathology report)
Total Lymph nodal yield
The total number of lymph nodes retrieved per patient as determined by final histopathological assessment.
Measured: Up to 2 weeks postoperatively (upon completion of final histopathology report)
Postoperative Morbidity and Mortality
The incidence of postoperative complications (graded according to the Clavien-Dindo classification), readmission, reoperation, and mortality rates.
Measured: Baseline, postoperative day 30, and at 3, 6, and 9 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirollos Samir Fathy Messiha, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638956
- Sponsor's protocol ID
- 36265MD41060/4/26
- Acronym
- ICG
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the results reported in this study will be shared upon reasonable request to the principal investigator. In accordance with the study's ethical approval, confidentiality will be strictly maintained using coded data.
Publications
Galema HA, Meijer RPJ, Lauwerends LJ, Verhoef C, Burggraaf J, Vahrmeijer AL, Hutteman M, Keereweer S, Hilling DE. Fluorescence-guided surgery in colorectal cancer; A review on clinical results and future perspectives. Eur J Surg Oncol. 2022 Apr;48(4):810-821. doi: 10.1016/j.ejso.2021.10.005. Epub 2021 Oct 9.
PubMed 34657780Wexner S, Abu-Gazala M, Boni L, Buxey K, Cahill R, Carus T, Chadi S, Chand M, Cunningham C, Emile SH, Fingerhut A, Foo CC, Hompes R, Ioannidis A, Keller DS, Knol J, Lacy A, de Lacy FB, Liberale G, Martz J, Mizrahi I, Montroni I, Mortensen N, Rafferty JF, Rickles AS, Ris F, Safar B, Sherwinter D, Sileri P, Stamos M, Starker P, Van den Bos J, Watanabe J, Wolf JH, Yellinek S, Zmora O, White KP, Dip F, Rosenthal RJ. Use of fluorescence imaging and indocyanine green during colorectal surgery: Results of an intercontinental Delphi survey. Surgery. 2022 Dec;172(6S):S38-S45. doi: 10.1016/j.surg.2022.04.016.
PubMed 36427929Cassinotti E, Al-Taher M, Antoniou SA, Arezzo A, Baldari L, Boni L, Bonino MA, Bouvy ND, Brodie R, Carus T, Chand M, Diana M, Eussen MMM, Francis N, Guida A, Gontero P, Haney CM, Jansen M, Mintz Y, Morales-Conde S, Muller-Stich BP, Nakajima K, Nickel F, Oderda M, Parise P, Rosati R, Schijven MP, Silecchia G, Soares AS, Urakawa S, Vettoretto N. European Association for Endoscopic Surgery (EAES) consensus on Indocyanine Green (ICG) fluorescence-guided surgery. Surg Endosc. 2023 Mar;37(3):1629-1648. doi: 10.1007/s00464-023-09928-5. Epub 2023 Feb 13.
PubMed 36781468
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Indocyanine Green (ICG) Fluorescence-Guided Lymphatic Mapping During Laparoscopic Colon Cancer Resection
- ClinicalTrials.gov ID
- NCT07638956
- Acronym / sponsor ID
- ICG / 36265MD41060/4/26
- Conditions
- Colon Cancer, ICG (Indocyanine Green)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 10 Jun 2026 (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 aim of this study is to evaluate the role of indocyanine green (ICG) injection in fluorescence-guided lymphatic mapping during laparoscopic colon cancer resection. This is a single-center prospective single-arm pilot clinical study that will include at least 25 patients with resectable colon cancer. All enrolled patients will undergo intraoperative subserosal ICG-guided lymphatic mapping before dissection, and intravenous ICG perfusion assessment before anastomosis. The primary goal is to determine the proportion of analyzable pN+ patients in whom all metastatic lymph nodes identified on final histopathology are located within the ICG-mapped lymphatic basin.
Detailed description
Adequate lymphadenectomy is a key component of curative colon cancer surgery because lymph node status is essential for accurate staging and postoperative treatment planning. Indocyanine green (ICG) fluorescence imaging has become increasingly used intraoperatively to make otherwise invisible lymphatic pathways visible in real time.
Preoperative and Perioperative Care:
All patients will undergo standard preoperative evaluation including colonoscopy with biopsy confirmation, baseline laboratory investigations, carcinoembryonic antigen measurement, and contrast-enhanced CT staging. Perioperative care will follow an enhanced recovery pathway including counseling, thromboembolism prophylaxis, antibiotic prophylaxis, multimodal analgesia, early mobilization, and early oral intake.
Operative Protocol:
Laparoscopic oncologic colectomy will be performed according to tumor location. Fluorescence imaging will be performed using the KARL STORZ IMAGE1 STM Rubina platform. Indocyanine green will be injected subserosally around the tumor in four quadrants whenever feasible. Near-infrared imaging will then be used to identify lymphatic channels and nodal basins before definitive mesenteric division. Any fluorescence-related modification of the extent of mesenteric excision or pedicle clearance will be recorded prospectively. Before bowel anastomosis, intravenous indocyanine green will be used to assess perfusion of the bowel ends by near-infrared fluorescence imaging.
Pathology and Follow-up:
The mapped area will be identified on the specimen by sutures or clips or separately labeled packets, allowing the pathologist to record metastatic lymph nodes as located within or outside the ICG-mapped basin. Patients will be followed during hospital admission and for 3, 6, and 9 months after surgery to record postoperative complications, final histopathological outcomes, and morbidity according to the Clavien-Dindo classification
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICG-Guided Surgery | Experimental | Drug: Indocyanine green (ICG) injection for intraoperative lymph node imaging, Procedure: Laparoscopic Colon Cancer ResectionAll patients enrolled in this single-arm study will undergo intraoperative subserosal injection of Indocyanine Green (ICG) for fluorescence-guided lymphatic mapping prior to mesenteric dissection. Additionally, an intravenous ICG injection will be administered to assess bowel perfusion before creating the anastomosis during laparoscopic colon cancer resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >= 18 years.
- Histologically confirmed colon adenocarcinoma.
Key exclusion criteria (6 listed)
- Emergency surgery (obstruction/perforation with sepsis) requiring urgent operation.
- Known allergy or contraindication to ICG (including prior anaphylaxis to ICG; severe hypersensitivity history per anesthesia assessment).
- Pregnancy or breastfeeding.
- Severe hepatic failure (because ICG clearance is hepatobiliary) or other contraindication determined by anesthesia team.
- Planned palliative resection only.
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) injection for intraoperative lymph node imagingIndocyanine green is injected subserosally around the tumor in four quadrants for lymphatic mapping. Additionally, intravenous ICG is administered before bowel anastomosis to assess perfusion of the bowel ends using near-infrared fluorescence imaging. | Drug | ICG-Guided Surgery |
| Laparoscopic Colon Cancer ResectionStandard laparoscopic colectomy with oncologic lymphadenectomy performed according to institutional practice. | Procedure or surgery | ICG-Guided Surgery |
Primary outcome
Proportion of analyzable pN+ patients with all metastatic lymph nodes located within the ICG-mapped lymphatic basin
Time frame: Up to 2 weeks postoperatively (upon completion of final histopathology report)
This outcome evaluates the accuracy of ICG mapping. It is measured as the proportion of analyzable pN+ patients in whom all metastatic lymph nodes identified on final histopathology are located within the ICG-mapped lymphatic basin.
6 secondary outcomes
Successful intraoperative visualization of lymphatic drainage (Feasibility rate)
Time frame: Intraoperative
Frequency of fluorescence-guided modification of mesenteric excision
Time frame: Intraoperative
Change in the planned transection line due to perfusion assessment
Time frame: Intraoperative
Metastatic lymph nodes identified outside conventional resection margins
Time frame: Up to 2 weeks postoperatively (upon completion of final histopathology report)
Total Lymph nodal yield
Time frame: Up to 2 weeks postoperatively (upon completion of final histopathology report)
Postoperative Morbidity and Mortality
Time frame: Baseline, postoperative day 30, and at 3, 6, and 9 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Background: PubMed 34657780Galema HA, Meijer RPJ, Lauwerends LJ, Verhoef C, Burggraaf J, Vahrmeijer AL, Hutteman M, Keereweer S, Hilling DE. Fluorescence-guided surgery in colorectal cancer; A review on clinical results and future perspectives. Eur J Surg Oncol. 2022 Apr;48(4):810-821. doi: 10.1016/j.ejso.2021.10.005. Epub 2021 Oct 9.
- Background: PubMed 36427929Wexner S, Abu-Gazala M, Boni L, Buxey K, Cahill R, Carus T, Chadi S, Chand M, Cunningham C, Emile SH, Fingerhut A, Foo CC, Hompes R, Ioannidis A, Keller DS, Knol J, Lacy A, de Lacy FB, Liberale G, Martz J, Mizrahi I, Montroni I, Mortensen N, Rafferty JF, Rickles AS, Ris F, Safar B, Sherwinter D, Sileri P, Stamos M, Starker P, Van den Bos J, Watanabe J, Wolf JH, Yellinek S, Zmora O, White KP, Dip F, Rosenthal RJ. Use of fluorescence imaging and indocyanine green during colorectal surgery: Results of an intercontinental Delphi survey. Surgery. 2022 Dec;172(6S):S38-S45. doi: 10.1016/j.surg.2022.04.016.
- Background: PubMed 36781468Cassinotti E, Al-Taher M, Antoniou SA, Arezzo A, Baldari L, Boni L, Bonino MA, Bouvy ND, Brodie R, Carus T, Chand M, Diana M, Eussen MMM, Francis N, Guida A, Gontero P, Haney CM, Jansen M, Mintz Y, Morales-Conde S, Muller-Stich BP, Nakajima K, Nickel F, Oderda M, Parise P, Rosati R, Schijven MP, Silecchia G, Soares AS, Urakawa S, Vettoretto N. European Association for Endoscopic Surgery (EAES) consensus on Indocyanine Green (ICG) fluorescence-guided surgery. Surg Endosc. 2023 Mar;37(3):1629-1648. doi: 10.1007/s00464-023-09928-5. Epub 2023 Feb 13.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the results reported in this study will be shared upon reasonable request to the principal investigator. In accordance with the study's ethical approval, confidentiality will be strictly maintained using coded data.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Indocyanine green (ICG) injection for intraoperative lymph node imaging and Laparoscopic Colon Cancer Resection in people with Colon Cancer and ICG (Indocyanine Green), run by Tanta University.
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 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: opening soon, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kirollos S Fathy Messiha, Asiistant Lecturer (+201012049716, Kerles.samir@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of analyzable pN+ patients with all metastatic lymph nodes located within the ICG-mapped lymphatic basin (time frame: Up to 2 weeks postoperatively (upon completion of final histopathology report)). 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 NCT07638956, which also lists 3 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 12 Jun 2026.