Liver Cancer (Locally Advanced or Metastatic), Liver Cancer Stage IIIa, Liver Cancer Stage IIIb, Liver Cancer Stage IIIc, Liver Cancer Stage IV, Pancreatic Cancer, Pancreatic Cancer Non-resectable, Pancreatic Cancer Stage III, Pancreatic Cancer Stage IV
Conditions
Keywords
Locally Advanced, Unresectable, Metastatic
Brief summary
The goal of this study is to assess the overall success of energy delivery during treatment using the ultrasound guided microwave ablation device in patients with locally advanced, unresectable, or metastatic cancer. Secondly, this study aims to explore the procedural/clinical safety of treatment with the device and the antitumor effect following treatment with the device.
Interventions
DEVICEEUS-Guided MWA Device
The rationale of this study is to generate preliminary data on the functionality and safety of Creo's MicroBlate™ Fine device when used under EUS guidance. The results generated from this study will inform any decisions regarding subsequent pivotal trials and may support the integration of this approach into clinical practice for anatomically challenging tumors.
Sponsors
Banner Health
Creo Medical Limited
CreoMed, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a prospective feasibility study; therefore, no randomization is being performed.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female ≥18 years of age * Willing and able to provide written informed consent * Histologically confirmed locally advanced, unresectable or metastatic cancer (Stage III or IV) * At least 1 tumor that is indicated for MWA, and the location of target tumor must be accessible via EUS through the gastric wall (eg, pancreas, liver, etc). * The tumor(s) must be ≥1 cm in diameter
Exclusion criteria
* Participant is a candidate for upfront resection of pancreatic cancer * Participation in another clinical trial that involves local ablation or any other local therapy that could affect the target organ or lesions treated in this study * Any condition that, in the opinion of the investigator, may increase the risk to the participant's safety or well-being
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the success of energy delivery during treatment with the device | From first MWA procedure to the end of treatment at Week 5 or 9 | Success of energy delivery as measured by presence of echogenic microbubbles visualized during EUS imaging AND generator-confirmed energy delivery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the procedural safety | From first MWA treatment to final long term follow up at week 52 | Procedural safety as measured by absence of unplanned terminations or major complications during or immediately following (within 2 weeks) of ablation procedure. |
| To evaluate clinical safety | From first MWA treatment to final long term follow up at week 52 | Clinical safety as measured by occurrence and severity of AEs, SAEs, and ADEs related to the procedure. |
| To evaluate tolerability of treatment with the device | From first MWA treatment to final long term follow up at week 52 | Tolerability as measured by patient-reported Numeric Pain Rating Scale pain score. Numeric Pain Rating Scale is scored 0-10, where "0" represents "no pain" and "10" represents "worst pain imaginable." |
| To evaluate the early antitumor effect of treatment with the device by change in size of target lesion. | From first MWA treatment to follow up visit at 6 months from first treatment | Early antitumor effect at 3 months and 6 months as measured by percent change in target lesion diameter on CT/MRI or maximal lesion diameter on EUS. |
| To evaluate the early antitumor effect of treatment with the device by RECIST. | Time Frame: From first MWA treatment to follow up visit at 6 months from first treatment | Early antitumor effect at 3 months and 6 months as measured by Objective response rate (ORR), defined as complete response (CR) + partial response (PR) on CT/MRI, per Response Evaluation Criteria in Solid Tumors (RECIST). |
Countries
United States
Contacts
CONTACTNeil Sharma, MD
PRINCIPAL_INVESTIGATORNeil Sharma, MD
Banner Health (Banner MD Anderson Cancer Center at Gateway Medical Center)
Outcome results
None listed