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New treatment option for Colorectal Cancer
Official title Intraoperative Indocyanine Green Fluorescence Angiography in Colorectal Surgery to Prevent Anastomotic Leakage
ClinicalTrials.gov ID: NCT05168839
What this study is testing
What is FLUO+ : Intraoperative fluorescence angiography (IOFA) with indocyanine green (ICG).?
FLUO+ : Intraoperative fluorescence angiography (IOFA) with indocyanine green (ICG). is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for colorectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Colorectal cancer (CRC) is the fourth most commonly diagnosed cancer in the world and the third in France. Its incidence is steadily rising in developing nations.
- Phase 3: a large, late-stage study
- Time commitment: about 36 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult patients (age \>18 years)
- Scheduled to undergo elective left colectomy or high rectal resection for cancer with intraperitoneal anastomosis.
- Signed consent
- Affiliated to the French social security system (CMU included).
You likely can't join if
- Emergent surgery.
- Rectal cancer requiring total mesorectal excision and anastomosis below the peritoneal reflexion.
- Colon cancer requiring total or subtotal colectomy defined as a right colectomy extended to the splenic flexure or more).
- Colon cancer requiring transverse colectomy.
- Recurrent colorectal cancer.
- Locally advanced colorectal cancer requiring multi-visceral excision.
See the full eligibility criteria
- Adult patients (age \>18 years)
- Scheduled to undergo elective left colectomy or high rectal resection for cancer with intraperitoneal anastomosis.
- Signed consent
- Affiliated to the French social security system (CMU included).
- Emergent surgery.
- Rectal cancer requiring total mesorectal excision and anastomosis below the peritoneal reflexion.
- Colon cancer requiring total or subtotal colectomy defined as a right colectomy extended to the splenic flexure or more).
- Colon cancer requiring transverse colectomy.
- Recurrent colorectal cancer.
- Locally advanced colorectal cancer requiring multi-visceral excision.
- History of colectomy.
- Associated concomitant resection of other organ (liver, etc.).
- Previous pelvic radiotherapy for pathology unrelated to diagnosis with colon cancer e.g. treatment for prostate cancer.
- Inflammatory bowel disease.
- History of known allergy to indocyanine.
- Pregnant patients.
- Refusal to participate or inability to provide informed consent.
- Protected adults (individuals under guardianship by court order).
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Annecy, France
- Besançon, France
- Bourgoin, France
- Dijon, France
- La Tronche, France
- Lille, France
- Lyon, France
- Marseille, France
- Nancy, France
- Paris, France
- Pontoise, France
- Reims, France
- Rennes, France
- Rouen, France
- Saint-Herblain, France
- Strasbourg, France
- Toulouse, France
- Tours, France
- Vandœuvre-lès-Nancy, France
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 36 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Annecy, France; Besançon, France; Bourgoin, France; Dijon, France; La Tronche, France and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.