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New treatment option for Pancreatic Cystic Neoplasm
Official title Endoscopic Ultrasound-Guided Chemoablation for the Treatment of Pancreatic Cystic Neoplasms
ClinicalTrials.gov ID: NCT07529483
What this study is testing
What is Gemcitabine Hydrochloride?
Gemcitabine Hydrochloride is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for pancreatic cystic neoplasm.
Also referred to as dFdCyd, Difluorodeoxycytidine Hydrochloride.
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
- This phase II trial tests the effect of endoscopic ultrasound (EUS)-guided chemoablation in treating patients with pancreatic cysts. Pancreatic cancer is a fatal disease that is difficult to diagnose at an early stage, and the five-year survival rate is currently less than 10%.
- Phase 2: a mid-size study of how well it works
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
- Age \> 18 years
- A diagnosis of a pancreatic cystic neoplasm (PCN) confirmed by endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) including cyst fluid...
- The pancreatic cystic lesion (PCL) measures at least 1 cm in diameter on CT, MRI/MRCP, or EUS
- This cohort may include patients with PCNs previously treated with other ablative modalities include EUS-radiofrequency ablation (RFA) (NCT05961982...
- The patient is not a surgical candidate. Common clinical scenarios include-
You likely can't join if
- Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in the view of the investigator makes it unsafe for the patient...
- Any psychiatric disorder making reliable informed consent impossible
- Pregnancy or breast-feeding
- Pregnant patients will be excluded due to confounding variables
- Contraindication to general anesthesia after review by Ohio State University (OSU) Preoperative Assessment Clinic (OPAC)
- Non-English speaking individuals are excluded because study materials, consent forms, and validated patient-reported assessments are available only...
See the full eligibility criteria
- Age \> 18 years
- A diagnosis of a pancreatic cystic neoplasm (PCN) confirmed by endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) including cyst fluid next-generation sequencing (NGS) and/or EUS-needle based confocal laser...
- The pancreatic cystic lesion (PCL) measures at least 1 cm in diameter on CT, MRI/MRCP, or EUS
- This cohort may include patients with PCNs previously treated with other ablative modalities include EUS-radiofrequency ablation (RFA) (NCT05961982, institutional review board [IRB]: 2023C0004) or EUS-pulsed electric...
- The patient is not a surgical candidate. Common clinical scenarios include-
- Cirrhosis of the liver (common clinical scenario)
- Advanced (≥ 75 years) age (common clinical scenario)
- Morbid obesity
- Significant cardiorespiratory comorbidity
- Patient's choice (patient elects for non-surgical management)
- Other significant comorbid conditions that impose prohibitive surgical risks
- Estimated life expectancy of at least 1 year
- Capable of giving written informed consent or has a legally authorized representative (LAR) to consent for them
- Women of childbearing potential must have a negative pregnancy test (serum/urine) on the day of treatment. Pregnancy testing is the routine standard of care practice in the endoscopy laboratory for all patients...
- Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in the view of the investigator makes it unsafe for the patient to participate in the study
- Any psychiatric disorder making reliable informed consent impossible
- Pregnancy or breast-feeding
- Pregnant patients will be excluded due to confounding variables
- Contraindication to general anesthesia after review by Ohio State University (OSU) Preoperative Assessment Clinic (OPAC)
- Non-English speaking individuals are excluded because study materials, consent forms, and validated patient-reported assessments are available only in English, and interpreter-mediated consent could compromise...
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States. 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.