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Monocentric, open-label, single-arm, phase I/II clinical trial to evaluate the use of the ONCOGREEN galenic formulation consisting of indocyanine green (ICG) with autologous extracellular vesicles (EVs) for in vivo diagnostics of solid neoplasms undergoing surgical removal - ONCOGREEN study
EU CTIS ID: 2025-521273-14-00
What this study is testing
Phase I To evaluate safety and tolerability of OncoGreen and to determine the dose for the phase II (RP2D) of OncoGreen in patients with gastrointestinal tract tumors undergoing surgery with curative intent. Phase II Improvement of in-vivo visualization of neoplastic tissue and tumor margins during surgical oncology procedures through fluorescence imaging techniques emitted by the ICG molecule delivered to neoplastic tissue via autologous extracellular vesicles (EVs).
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Be able to provide written informed consent for the study, particularly for the use of EVs loaded with ICG that are isolated from their own plasma through a plasmapheresis procedure with subsequent re-infusion of the galenic preparation OncoGreen.
- Be aged 18 years or older at the time of signing the informed consent.
- Have a histological or instrumental diagnosis of solid tumor of the digestive tract (primary and/or metastatic colon-rectal tumors, gastric tumors, tumors of the hepato-bilio-pancreatic and neuroendocrine districts) indicating the need for surgical resection under general anesthesia.
- Have a performance status of 0-1 on the ECOG performance scale.
- Meet technical and anesthesiologic eligibility for oncological surgical intervention for curative purposes. Specifically, routine hematological, hepatic, renal, and cardiorespiratory function tests compatible with extensive oncological surgery following good clinical practice.
- Be eligible for preoperative plasmapheresis procedure as evaluated by a specialist in transfusion medicine (including clinical reassessment, complete blood count, comprehensive biochemistry with electrolytes (Ca/Na/K), complete coagulation profile, and recent ECG.
You likely can't join if
- History of allergies or reactions to contrast agents or ICG.
- Chronic therapies or general, metabolic, or hematological conditions that contraindicate surgery or plasma collection through plasmapheresis.
- Psychiatric disorders or substance abuse that would interfere with the necessary cooperation for the study.
- Pregnancy or breastfeeding or planning to conceive from the clinical evaluation for enrollment up to 120 days after the surgical intervention, a period further extendable based on specific oncological indications for the individual case, for example, the need for adjuvant therapy.
- During Phase II, patients who undergo plasmapheresis and EVs injection but, for whatever reason unrelated to the study, are not able to undergo surgery or receive intraoperative visualization, will be excluded from the study.
- Ongoing therapies with drugs significantly interfering with hepatic function and ICG clearance (alloperidol, nitrofurantoine, phenobarbital, atropine, scopolamine, primidone).
See the full eligibility criteria
- Be able to provide written informed consent for the study, particularly for the use of EVs loaded with ICG that are isolated from their own plasma through a plasmapheresis procedure with subsequent re-infusion of the galenic preparation OncoGreen.
- Be aged 18 years or older at the time of signing the informed consent.
- Have a histological or instrumental diagnosis of solid tumor of the digestive tract (primary and/or metastatic colon-rectal tumors, gastric tumors, tumors of the hepato-bilio-pancreatic and neuroendocrine districts) indicating the need for surgical resection under general anesthesia.
- Have a performance status of 0-1 on the ECOG performance scale.
- Meet technical and anesthesiologic eligibility for oncological surgical intervention for curative purposes. Specifically, routine hematological, hepatic, renal, and cardiorespiratory function tests compatible with extensive oncological surgery following good clinical practice.
- Be eligible for preoperative plasmapheresis procedure as evaluated by a specialist in transfusion medicine (including clinical reassessment, complete blood count, comprehensive biochemistry with electrolytes (Ca/Na/K), complete coagulation profile, and recent ECG.
- Have no active infection for HIV, HCV, HBV and Syphilis at enrollment proved by negativity of PCR for viral infection or negativity of a second level test for Syphilis in case of positive serology.
- History of allergies or reactions to contrast agents or ICG.
- Chronic therapies or general, metabolic, or hematological conditions that contraindicate surgery or plasma collection through plasmapheresis.
- Psychiatric disorders or substance abuse that would interfere with the necessary cooperation for the study.
- Pregnancy or breastfeeding or planning to conceive from the clinical evaluation for enrollment up to 120 days after the surgical intervention, a period further extendable based on specific oncological indications for the individual case, for example, the need for adjuvant therapy.
- During Phase II, patients who undergo plasmapheresis and EVs injection but, for whatever reason unrelated to the study, are not able to undergo surgery or receive intraoperative visualization, will be excluded from the study.
- Ongoing therapies with drugs significantly interfering with hepatic function and ICG clearance (alloperidol, nitrofurantoine, phenobarbital, atropine, scopolamine, primidone).
The study team makes the final eligibility decision.
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.