80 Participants Needed

Brachytherapy for Pancreatic Cancer

Recruiting at 1 trial location
KP
CC
KP
Overseen ByKristy Perez
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: CivaTech Oncology
Must be taking: Gemcitabine, FOLFIRINOX
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves surgery and previous chemotherapy, it's best to discuss your current medications with the trial team.

What data supports the effectiveness of the treatment Directional Brachytherapy Source Implant, CivaSheet, Directional Brachytherapy Source Implant, Planar LDR Source for pancreatic cancer?

The CivaSheet, a novel implantable mesh with directional low-dose radiation sources, has shown promise in improving local control of pancreatic cancer by targeting areas with close or positive surgical margins, which are linked to higher recurrence rates. Early patient outcomes suggest it may help achieve better surgical margins, potentially leading to improved survival rates.12345

Is the CivaSheet safe for use in humans?

The CivaSheet is an FDA-cleared implantable device used in surgeries, designed to protect sensitive areas like the bowel from radiation. It has been used in patients with pancreatic cancer, and early outcomes suggest it is safe for human use.12346

How is the CivaSheet treatment different from other treatments for pancreatic cancer?

The CivaSheet is unique because it is an implantable sheet that delivers targeted radiation directly to the surgical margins during surgery, using a matrix of Palladium-103 sources shielded on one side to protect sensitive tissues. This approach helps address the challenge of achieving negative surgical margins, which is crucial for reducing local recurrences and improving survival in pancreatic cancer patients.23789

What is the purpose of this trial?

Initial study to evaluate local control and the preferred method of attachment of the CivaSheet in the setting of suspected close or positive margins at the time of surgical tumor removal.

Research Team

Joshua E. Meyer | Fox Chase Cancer ...

Joshua E. Meyer

Principal Investigator

Fox Chase Cancer Center

Eligibility Criteria

This trial is for adults over 18 with borderline resectable or locally advanced pancreatic cancer who've had specific pre-surgery treatments but no prior radiation in the area. They must be able to undergo anesthesia and surgery (Whipple procedure or distal pancreatectomy), not be pregnant, breastfeeding, or have metastatic disease.

Inclusion Criteria

Subject signed inform consent
Not pregnant or breast feeding
The patient's surgical margins show that the cancer is close to the edge of the removed tissue.
See 9 more

Exclusion Criteria

You have a documented history of alcoholism or drug abuse.
Participant in other clinical trials
My tumor has come back or was surgically removed before.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Implantation

Patients undergo pancreatic cancer resection and receive a CivaSheet LDR directional brachytherapy implant at the time of surgery

1 week
1 visit (in-person)

Post-operative Monitoring

Patients are monitored for adverse radiation toxicity effects and local cancer recurrence rate

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment, including 2-year survival rates

2 years

Treatment Details

Interventions

  • Directional Brachytherapy Source Implant
Trial Overview The study tests a new method called Directional Brachytherapy Source Implant during surgery for pancreatic cancer. It aims to see how well it works when there's a high risk of cancer left at the edges of where the tumor was removed.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Directional Brachytherapy Source ImplantExperimental Treatment1 Intervention
Patients undergoing a pancreatic cancer resection will receive a CivaSheet LDR directional brachytherapy implant at the time of surgery. The directional nature of the FDA cleared CivaSheet is expected to allow physicians to increase the radiation dose given to the surgical margin safely, reducing risk of recurrence without increasing radiation side effects.

Directional Brachytherapy Source Implant is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as CivaSheet for:
  • Pancreatic cancer
  • Localized tumors
🇪🇺
Approved in European Union as CivaSheet for:
  • Pancreatic cancer
  • Localized tumors
  • Soft tissue sarcomas

Find a Clinic Near You

Who Is Running the Clinical Trial?

CivaTech Oncology

Lead Sponsor

Trials
7
Recruited
310+

Findings from Research

The CivaDot brachytherapy source demonstrated excellent repeatability and reproducibility in primary source strength measurements, with less than 1.1% agreement across different measurement methods, indicating reliable performance for clinical use.
Dose distribution measurements showed that the CivaDot's predicted and measured dose rates were closely aligned, with differences generally within 2-3%, suggesting that the CivaDot can deliver precise radiation therapy effectively.
Dosimetric characterization of a new directional low-dose rate brachytherapy source.Aima, M., DeWerd, LA., Mitch, MG., et al.[2020]
The use of a novel implantable low dose rate (LDR) Pd-103 brachytherapy sheet in 11 patients with resectable or borderline resectable pancreatic cancer showed no procedural complications and added only 15 minutes to surgery time.
At a median follow-up of 13 months, 64% of patients were alive and 55% were disease-free, indicating promising clinical outcomes with minimal toxicity compared to traditional radiation methods.
First report on the feasibility of a permanently implantable uni-directional planar low dose rate brachytherapy sheet for patients with resectable or borderline resectable pancreatic cancer.Dault, JB., Todor, D., Kaplan, BJ., et al.[2021]
The CivaSheet is an FDA-cleared implantable device that uses low-dose-rate Palladium-103 to target areas at risk of cancer recurrence after surgery for borderline resectable pancreatic cancer, potentially improving outcomes by addressing close or positive surgical margins.
This innovative approach allows for customized implantation during surgery, aiming to reduce local recurrences and improve overall survival, although the study also highlights the ongoing challenges in achieving negative margins in pancreatic cancer treatment.
CivaSheet intraoperative radiation therapy for pancreatic cancer.Taylor, RJ., Todor, D., Kaplan, BJ., et al.[2022]

References

Dosimetric characterization of a new directional low-dose rate brachytherapy source. [2020]
First report on the feasibility of a permanently implantable uni-directional planar low dose rate brachytherapy sheet for patients with resectable or borderline resectable pancreatic cancer. [2021]
CivaSheet intraoperative radiation therapy for pancreatic cancer. [2022]
Intraoperative implantation of a mesh of directional palladium sources (CivaSheet): Dosimetry verification, clinical commissioning, dose specification, and preliminary experience. [2018]
SU-E-T-319: Monte Carlo Characterization of a New Directional Pd-103 High Dose Rate Source for Brachytherapy Application. [2019]
Application of a directional palladium-103 brachytherapy device on a curved surface. [2019]
Treatment of unresectable pancreatic carcinoma by intraluminal brachytherapy in the duct of Wirsung. [2004]
Brachytherapy for pancreatic cancer: a review. [2005]
A pilot study of intraluminal brachytherapy using 125I seed strand for locally advanced pancreatic ductal adenocarcinoma with obstructive jaundice. [2023]
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