NCT05611034 In Vivo Lung Perfusion (IVLP) for Colorectal Cancer Metastatic to Lung
| NCT ID | NCT05611034 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University Health Network, Toronto |
| Condition | Lung Metastases |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2023-02-06 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2023-02-06 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is investigating a new technique for delivering chemotherapy directly into the lungs at the time of surgery. Delivering chemotherapy directly to the lungs could potentially kill any microscopic cancer cells that are present in the lungs at the time of surgery, while sparing other major organs in the body from the side effects of chemotherapy. This technique is called In Vivo Lung Perfusion (IVLP). At the University Health Network, this IVLP technique has been used recently in a Phase I study in patients with sarcoma, and we are now expanding on that experience to include patients with colorectal metastases. The purpose of this study is to test the safety of the IVLP technique and find the dose that seems right in humans. Participants are given oxaliplatin into one lung via IVLP and are watched very closely to see what side effects they have and to make sure the side effects are not severe. If the side effects are not severe, then more participants are asked to join the study and are given a higher dose of oxaliplatin. Participants joining the study later on will get higher doses of oxaliplatin than participants who join earlier. This will continue until a dose is found that causes severe but temporary side effects. Doses higher than that will not be given. The other lung will not be infused with anything, so that we can limit unforeseen toxicity to a single lung and see if one lung does better than the other.
Eligibility Criteria
Inclusion Criteria: 1. Diagnosis of Colorectal Carcinoma 2. Presence of bilateral pulmonary metastases 3. 3 or more lung lesions in total 4. Age 70 years or less 5. ECOG 0-2 6. Absence of extra-pulmonary disease, except liver metastases suitable to curative treatment. Exclusion Criteria: 1. Patient has previously received more than 1000 mg of oxaliplatin 2. Left Ventricular Ejection Fraction \<50% 3. History of significant pulmonary disease or pneumonitis 4. Pregnant or lactating females 5. Age 71 or older, or less than 18 years 6. Inability to understand the informed consent process 7. Hypersenstivity to oxaliplatin 8. Patients with Heparin-induced thrombocytopenia (HIT) 9. Patients who cannot receive cefazolin or methylprednisolone due to allergy or another reason can be included but will not receive the drug they cannot tolerate 10. Current participation in another therapeutic clinical trial
Contact & Investigator
Marcelo K Cypel, MD
PRINCIPAL INVESTIGATOR
University Health Network, Toronto
Frequently Asked Questions
Who can join the NCT05611034 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Lung Metastases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05611034 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05611034 currently recruiting?
Yes, NCT05611034 is actively recruiting participants. Contact the research team at jennifer.lister@uhn.ca for enrollment information.
Where is the NCT05611034 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT05611034 clinical trial?
NCT05611034 is sponsored by University Health Network, Toronto. The principal investigator is Marcelo K Cypel, MD at University Health Network, Toronto. The trial plans to enroll 10 participants.