Pancreas CancerPhase 1NCT03109041
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source
A Phase 1 study testing CivaSheet in people with Pancreas Cancer and Cancer, run by CivaTech Oncology at 1 site in United States.
Trial summary
This is a Phase I evaluation to determine the usefulness of a new brachytherapy device that utilizes active components (Palladium-103) of standard devices in a novel configuration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer, Cancer
- What is being tested?
- CivaSheet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2017to 30 Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject signed informed consent
- Age >/= 18 years
- Biopsy confirmed adenocarcinoma pancreatic cancer
- Patient capable of undergoing anesthesia
- Patient is a surgical candidate
- Patient selected to undergo pancreatic cancer resection
Show all 9Show fewer
- Patient will have known or suspected close/positive surgical margin
- Confirmed diagnosis of resectable pancreatic adenocarcinoma
- Will be prescribed standard Gemcitabine 1000 mg/m2 chemotherapy cycle
Who cannot join
- Pregnant or breast feeding
- Patient has metastatic disease
- Patient has had prior radiation therapy to the region for separate cancer
- Patient has had prior chemotherapy
- Any other invasive cancer in the past 5 years, except basal cell skin
- Recurrent or previously resected tumors
- Alcoholism/Drug abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
East Carolina University, Brody School of Medicine
Greenville, North Carolina, 27834
About this study
Official title: Initial Feasibility Study to Treat Resectable Pancreatic Cancer With the Permanently Implantable LDR CivaSheet®
This is a Phase I evaluation to determine the usefulness of a new brachytherapy device that utilizes active components (Palladium-103) of standard devices in a novel configuration. This study may benefit resectable pancreatic cancer patients by reducing the radiation dose to adjacent critical structures, while giving a therapeutic dose to diseased tissue, such as at a surgical margin.
- Conditions
- Pancreas Cancer, Cancer
- Being tested
- CivaSheet
- Keywords
- Whipple, brachytherapy, CivaSheet, CivaTech Oncology, radiation, intraoperative radiation, IORT, resectable pancreatic cancer, Pd-103
- Medical subject headings
- Pancreatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CivaSheetDevice
The FDA Cleared CivaSheet Directional Pd103 Brachytherapy Source is a planar radiation source which utilizes gold shielding in its construction. This device is radioactive on one side only, and is capable of safely delivering high doses of radiation to target areas even when placed directly adjacent to sensitive, healthy tissue or critical structures.
| Study group | Role | What they receive |
|---|---|---|
| Directional Brachytherapy Source Implant | Experimental | Patients undergoing a whipple procedure for pancreatic cancer will receive an implant at the time of surgery of the new CivaSheet directional brachytherapy device. 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. Receives: Device: CivaSheet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety & Toxicity of Delivering Primary Radiation Therapy with CivaSheet using the CTCAE 4.0 scale
Patients with resectable pancreatic cancer who are undergoing pancreatic cancer resection will be monitored for safety \& toxicities graded using the CTCAE 4.0 scale.
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start6 Sep 2017
- Primary completion1 Dec 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- CivaTech Oncology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109041
- Sponsor's protocol ID
- CT005
- Status last verified
- Sep 2023
- First submitted
- 6 Apr 2017
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Feasibility Study to Treat Resectable Pancreatic Cancer With the Permanently Implantable LDR CivaSheet®
- ClinicalTrials.gov ID
- NCT03109041
- Acronym / sponsor ID
- CT005
- Conditions
- Pancreas Cancer, Cancer
- Keywords
- Whipple, brachytherapy, CivaSheet, CivaTech Oncology, radiation, intraoperative radiation, IORT, resectable pancreatic cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- CivaTech OncologyIndustry (pharma, biotech, devices)
- Study start
- 6 Sep 2017 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 11 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I evaluation to determine the usefulness of a new brachytherapy device that utilizes active components (Palladium-103) of standard devices in a novel configuration. This study may benefit resectable pancreatic cancer patients by reducing the radiation dose to adjacent critical structures, while giving a therapeutic dose to diseased tissue, such as at a surgical margin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Directional Brachytherapy Source Implant | Experimental | Device: CivaSheetPatients undergoing a whipple procedure for pancreatic cancer will receive an implant at the time of surgery of the new CivaSheet directional brachytherapy device. 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject signed informed consent
- Age >/= 18 years
- Biopsy confirmed adenocarcinoma pancreatic cancer
- Patient capable of undergoing anesthesia
- Patient is a surgical candidate
Key exclusion criteria (7 listed)
- Pregnant or breast feeding
- Patient has metastatic disease
- Patient has had prior radiation therapy to the region for separate cancer
- Patient has had prior chemotherapy
- Any other invasive cancer in the past 5 years, except basal cell skin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CivaSheetThe FDA Cleared CivaSheet Directional Pd103 Brachytherapy Source is a planar radiation source which utilizes gold shielding in its construction. This device is radioactive on one side only, and is capable of safely delivering high doses of radiation to target areas even when placed directly adjacent to sensitive, healthy tissue or critical structures. | Device | Directional Brachytherapy Source Implant |
Primary outcome
Safety & Toxicity of Delivering Primary Radiation Therapy with CivaSheet using the CTCAE 4.0 scale
Time frame: 1.5 years
Patients with resectable pancreatic cancer who are undergoing pancreatic cancer resection will be monitored for safety \& toxicities graded using the CTCAE 4.0 scale.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CivaSheet in people with Pancreas Cancer and Cancer, run by CivaTech Oncology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety & Toxicity of Delivering Primary Radiation Therapy with CivaSheet using the CTCAE 4.0 scale (time frame: 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.