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New treatment option for Pancreatic Ductal Adenocarcinoma (PDAC)
Official title Early Feasibility Clinical Investigation to Assess YntraDose™ as a Neoadjuvant Treatment for LA-PDAC
ClinicalTrials.gov ID: NCT07155850
What this study is testing
- What it's testing
- The goal of this clinical investigation is to learn if a new type of radiotherapy works to treat pancreatic cancer that cannot be removed surgically. It will also learn about the safety of the new treatment when combined with chemotherapy.
- Time commitment: about 7 months
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
- (Main):
- Histologically or cytologically proven Pancreatic Adenocarcinoma.
- Stage of disease defined as unresectable Locally Advanced Pancreatic Cancer.
- No prior radiotherapy for pancreatic cancer.
- Target tumour with a minimum diameter of 2.6 cm and a volume of from 9 to 34 ml.
You likely can't join if
- (Main):
- Evidence of distant metastases based on the restaging process after two months of induction chemotherapy identified using CT/MRI/18 FDG PET...
- Evidence of switch from unresectable status to resectable status of disease after two months of induction chemotherapy.
- More than one primary lesion, if one of the primary lesions is not a good candidate for debulking with YntraDose™, due to clinical reasons and/or...
- ECOG is higher than 1.
- History of malignancy in the last 3 years.
See the full eligibility criteria
- (Main):
- Histologically or cytologically proven Pancreatic Adenocarcinoma.
- Stage of disease defined as unresectable Locally Advanced Pancreatic Cancer.
- No prior radiotherapy for pancreatic cancer.
- Target tumour with a minimum diameter of 2.6 cm and a volume of from 9 to 34 ml.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Patient has acceptable hematological parameters including white and red blood counts, liver and renal function that makes them suitable to receive SoC chemotherapy as per local clinical practice.
- Life expectancy of ≥6 months at screening.
- (Main):
- Evidence of distant metastases based on the restaging process after two months of induction chemotherapy identified using CT/MRI/18 FDG PET assessment.
- Evidence of switch from unresectable status to resectable status of disease after two months of induction chemotherapy.
- More than one primary lesion, if one of the primary lesions is not a good candidate for debulking with YntraDose™, due to clinical reasons and/or decision made by the local MDTB.
- ECOG is higher than 1.
- History of malignancy in the last 3 years.
- Blood clotting disorders (INR \> 1.5, PLT \< 50,000/µl - risk of bleeding during organ puncture).
- Active systemic or local infection (e.g. peritonitis, abscess).
- Severe organ failure (e.g. end-stage liver, kidney, heart failure).
- Cardiological and other diseases that threaten the use of anesthesia.
- Pancreatitis (acute or exacerbation of chronic inflammation).
The study team makes the final eligibility decision.
Where it's taking place
- Roma, Italy
- London, United Kingdom
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 7 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 Roma, Italy; London, United Kingdom. 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.