Alpha Radiation Emitters Device For The Treatment Of Pancreatic Cancer Emitters For The Treatment Of Locally Advanced Pancreatic Cancer

Study Overview

Alpha Radiation Emitters Device for the Treatment of Pancreatic Cancer Emitters for the Treatment of Locally Advanced Pancreatic Cancer

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for advanced pancreatic cancer

This is a prospective, interventional, single-center, open label, single arm study. The study is designed to evaluate the feasibility and Safety of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Locally Advanced Pancreatic Cancer The study will be comprised of a screening period, DaRT insertion visit, 3 months follow up per subject and 2 years for accrual and trial completion. The total duration of the study will be 24 months from the DaRT insertion procedure. 15 patients with a safety interim analysis after the 5 first patients . patients with advanced pancreatic cancer will be recruited by the investigational site. Eligible patients who meet inclusion/exclusion criteria (as assessed during the screening period) will be invited to the site for the procedure of DaRT seeds insertion.

Pancreatic Cancer
Unresectable Pancreatic Cancer
Pancreatic Adenocarcinoma

DEVICE: DaRT seeds insertion

CTP-PANC-03

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-08-17	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-11-19
First Submitted that Met QC Criteria 2023-09-05	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-11-20
First Posted (ACTUAL) 2023-09-07	Results First Posted N/A	Last Verified 2024-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: DaRT Seeds Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds	DEVICE: DaRT seeds insertion An intratumoral insertion of radioactive sources [Ra-224 containing stainless-steel 316LVM tubes- (Alpha DaRT seeds)]. The seeds release by recoil into the tumor short-lived alpha-emitting atoms

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: DaRT Seeds

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

DEVICE: DaRT seeds insertion

An intratumoral insertion of radioactive sources [Ra-224 containing stainless-steel 316LVM tubes- (Alpha DaRT seeds)]. The seeds release by recoil into the tumor short-lived alpha-emitting atoms

Primary Outcome Measures	Measure Description	Time Frame
Feasibility- DaRT seed placement	Feasibility will be determined according to the rate of successful placement of DaRT seeds via imaging	Immediately following the insertion procedure
Safety- Adverse events, Safety will be determined according to the overall incidence of device-related SAE's graded according to CTCAE v5.0 criteria	Safety will be determined according to the overall incidence of device-related SAE's graded according to CTCAE v5.0 criteria	from DaRT-insertion up to 48 hours

Secondary Outcome Measures	Measure Description	Time Frame
To evaluate the Efficacy of the Alpha DaRT seeds for locally advanced pancreatic cancer	Local control evaluation according to RECIST v1.1	1 months and 3 months
To evaluate the Efficacy of the Alpha DaRT seeds by measuring the CA-19-9 markers levels	Change in CA 19-9 levels	1 months and 3 months
Efficacy - to evaluate what is the percent of the Tumor Coverage by the Alpha DaRT seeds	Tumor Coverage	immediately following the insertion procedure]
Efficacy- Alpha DaRT seeds	Overall incidence of device-related SAE's graded according to CTCAE v5.0 criteria	from DaRT-insertion up to initiation of a possible postablation therapy or up to a maximum three months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Liron Dimnik

Phone Number: +972-2-3737-7000

Email: LironD@alphatau.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically and/or cytologically proven NCCN locally advanced PC
Patients must have i) received at least one line of chemotherapy (any kind) OR ii) are medically unfit for further chemotherapy, AND iii) the tumor is still not deemed as resectable with radical surgery, or the patient does not wish to go through surgery.
DaRT indication validated by a multidisciplinary team.
Measurable lesion per RECIST (version 1.1) criteria
TC at Verona's center (not been over a month)
Lesion size ≤ 5 cm in the longest diameter
Age ≥18 years old
ECOG Performance Status Scale ≤ 2
Life expectancy is more than 6 months
WBC ≥ 3500/μl, granulocyte ≥ 1500/μl
Platelet count ≥60,000/μl
Calculated or measured creatinine clearance ≥ 30cc/min. Calculated or measured creatinine clearance can be ≥ 40cc/min given stability of creatinine levels over the past three weeks (at least 1 test per week).
AST and ALT ≤ 2.5 X upper limit of normal (ULN)
INR < 1.4 for patients not on Warfarin
Subjects are willing and able to sign an informed consent form
Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test before the Ra-224 implantation and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after brachytherapy.
Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.

Concomitant chemotherapy or immunotherapy within the past 4 weeks
Prior radiation therapy to the pancreas
CA 19-9 > 1000 Units/ml
Fit for surgical exploration unless the patient refuses surgery
Known hypersensitivity to any of the components of the treatment.
Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.
Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy (not including cholangitis) or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints.
Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
Patient requires treatment not specified in this protocol which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT.
Patients do not agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.
Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.
High probability of protocol non-compliance (in opinion of investigator).
Breastfeeding women or women of childbearing potential unwilling or unable to use an acceptable contraceptive method to prevent pregnancy for 3 months after RT.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Salvatore Paiella, MD, Pancreas Institute - Integrated University Hospital of Verona

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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