Barrett EsophagusPhase 3OedisseNCT01209013
Safety of Photodynamic Therapy (PDT) in the Ablation of High-grade Dysplasia (HGD) in Barrett's Esophagus (BE)
A Phase 3 study testing Medlight PDT Balloon, Endoscopy and Endoscopy with biopsy in people with Barrett Esophagus, run by Pinnacle Biologics Inc..
Trial summary
Photodynamic therapy (PDT) uses a combination of a drug, porfimer sodium, and a light from a non heated laser. The activation of the drug is done by lighting of abnormal areas using a fiber optic device. The fiber optic device is a very fine fiber (like a fishing line) that permits transmission of light. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett Esophagus
- What is being tested?
- Medlight PDT Balloon, Endoscopy and Endoscopy with biopsy
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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
- Patients are males or females aged 18 or older.
- Patients have been diagnosed with biopsy-proven HGD in BE.
- Non-menopausal or non-surgically sterilized female patients must have a negative serum beta-HCG at the time of entry into the study.
- Non-menopausal or non-surgically sterilized female patients must use a medically acceptable form of birth control.
- Patients must sign an Informed Consent Form, which must comply with the ICH guidelines and local requirements.
Who cannot join
- Patients who have previously received PDT for HGD in BE.
- Patients who have previously undergone radiation therapy to the chest.
- Patients with known porphyria or known hypersensitivity to porphyrins or any excipients of the porfimer sodium.
- Patients who have esophageal cancer or in whom esophageal cancer, lymph node involvement, or metastases cannot be ruled out based on the pathology report, endoscopic ultrasonography (EUS), computed tomography (CT) scan or other diagnostic methods used in current practice no more than 30 days prior to date of consent.
- Patients with any acute or chronic medical or psychological illnesses as judged clinically significant by the investigator to preclude PDT procedure.
- Patients with a presence or history of neoplasms (treated during the last five years prior to study entry) other than carcinoma in situ of the cervix or basal carcinoma of the skin.
Show all 17Show fewer
- Patients with esophageal strictures, esophageal diverticula, esophageal or gastric varices.
- Patients with known contraindications to analgesia or endoscopy.
- Patients with blood parameters of Grade 3 or higher on the Common Terminology Criteria for Adverse Events (CTCAE).
- Patients with unstable cardiovascular disease (Class III and IV cardiovascular disease according to the New York Heart Association's functional criteria).
- Patients with esophageal ulcers > 1 cm in diameter.
- Patients with tracheoesophageal or bronchoesophageal fistula.
- Patients with chronic/acute dermatologic conditions (e.g., urticaria, eczema, sunburn).
- Patients under anticoagulant therapy (only for the subgroup of 12 patients who will consent to provide tissue samples in order to determine the concentrations of oligomers).
- Patients with severe renal or hepatic impairment with parameters of Grade 3 or higher on the CTCAE.
- Patients who have been treated with any investigational drug during 60 days prior to the screening visit.
- Patients who are unable or unwilling to complete the follow-up evaluations required for the study.
About this study
Official title: Multicenter, Prospective, Open-label, Single-arm Phase IIIb/IV Clinical Study on the Safety of Photodynamic Therapy With Porfimer Sodium for Injection for the Ablation of High-grade Dysplasia in Barrett's Esophagus
Photodynamic therapy (PDT) uses a combination of a drug, porfimer sodium, and a light from a non heated laser. The activation of the drug is done by lighting of abnormal areas using a fiber optic device. The fiber optic device is a very fine fiber (like a fishing line) that permits transmission of light. The fiber optic device is inserted into a diffusing balloon device to ensure the good positioning of the fiber optic within the esophagus (food pipe). It is thought that the size and the flexibility of a new diffusing balloon device could improve the safety profile of the photodynamic treatment by reducing the risk of narrowing or closure of the food pipe (esophageal stenosis) sometimes occurring after treatment.
This research study will evaluate the safety and effectiveness of PDT with porfimer sodium using a new diffusing balloon device for light application in the removal of high-grade dysplasia (HGD, precancerous change in the food pipe tissue) in Barrett's esophagus (BE). This study will provide advanced knowledge about phototoxicity (reaction similar to sunburn) and esophageal stenosis, main risks with this therapy. It will involve 75 patients with HGD in BE across North America and Europe and will last between 13 and 16 weeks. In addition, concentrations of porfimer sodium in the esophageal tissue will be analyzed in a subgroup of patients.
Read the detailed description
Patients with biopsy-confirmed HGD in BE will be evaluated to confirm eligibility. Prior to enrollment, all inclusion and exclusion criteria will be verified. Medical procedures including demographic information, medical/surgical history, concurrent medical conditions, physical exam (including vital signs, body weight, height, and skin color), degree of difficulty in swallowing; electrocardiogram, chest X-ray, clinical laboratory testing, concomitant medication intake and other therapy uses will be collected.
All patients will receive one course of PDT consisting of an intravenous injection of 2.0 mg/kg of porfimer sodium over 3-5 minutes followed by one or two endoscopic laser light applications. The first laser light application will be performed within 40-50 hours using a new diffusing balloon catheter. The second laser light application (without a diffusing balloon catheter) will be performed within 96-120 hours on those areas showing an insufficient response to the first application. Follow-ups (Weeks 4 and 13) will include some or all of the following procedures: physical exam; vital signs evaluation; body weight; endoscopy; skin, degree of difficulty in swallowing and esophageal stenosis assessment; and clinical laboratory check. All patients will be asked general open questions about any occurrence of adverse events, change in concurrent medical conditions, use of adjunctive therapy/procedure, and intake of concomitant medication. All patients will undergo rigorous systematic endoscopic biopsy surveillance at Week 13 (final visit).
Tissue concentration of oligomers (component of porfimer sodium) in normal and abnormal esophageal tissues will be determined in a subgroup of 12 patients. These patients will provide esophageal tissue samples before the porfimer sodium injection and on four separate occasions after the injection (22-26 hour-, 40-50 hour-, 96-120 hour-intervals, and 13 weeks).
All patients will be followed for three months.
- Conditions
- Barrett Esophagus
- Being tested
- Medlight PDT Balloon, Endoscopy, Endoscopy with biopsy, Electrocardiogram, Chest x-ray
- Keywords
- PDT, porfimer sodium, BE
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medlight PDT BalloonDevice
Medlight PDT Balloon will be used once to apply the laser light treatment
EndoscopyProcedure or surgery
Endoscopy will be performed to confirm eligibility, apply photodynamic therapy, assess esophageal condition and effectiveness of the therapy
Endoscopy with biopsyProcedure or surgery
Endoscopy with collection of esophageal tissue will be performed at screening to confirm eligibility and at Week 13 (final visit) to assess effectiveness
ElectrocardiogramProcedure or surgery
Resting electrocardiogram will be performed at screening (unless one has been performed within 30 days prior to screening) to measure heart function
Chest x-rayProcedure or surgery
A chest X-ray will be performed at screening (unless one has been performed within 90 days prior to screening) to provide several pictures of the chest to rule out any lung abnormalities
Blood collectionProcedure or surgery
Blood samples for laboratory tests will be taken to assess the overall condition
Tissue sample collectionProcedure or surgery
Esophageal tissue samples will be collected before the porfimer sodium injection and on four separate occasions after the injection (22-26 hour-, 40-50 hour-, 96-120 hour-intervals, and 13 weeks) to measure concentrations of oligomers in a subgroup of 12 patients.
| Study group | Role | What they receive |
|---|---|---|
| Medlight PDT Balloon | Experimental | Not described Receives: Device: Medlight PDT Balloon; Procedure: Endoscopy; Procedure: Endoscopy with biopsy; Procedure: Electrocardiogram; Procedure: Chest x-ray; Procedure: Blood collection; Procedure: Tissue sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of phototoxicity reaction
Measured: 3 months
Incidence of esophageal stenosis
Measured: 3 months
Secondary outcomes (3)
Proportion of patients with complete ablation (removal) of high-grade dysplasia
Complete ablation of high-grade dysplasia (pre-cancerous tissue) will be evaluated by biopsy
Measured: 3 months
Proportion of patients with adverse events as a measure of safety
Measured: 3 months
Measure oligomer concentrations
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2010 (estimated)
Why it stopped: Sponsor cancelled the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett EsophagusStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pinnacle Biologics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01209013
- Sponsor's protocol ID
- MA-PO-PHOEST07-01
- Acronym
- Oedisse
- Status last verified
- May 2012
- First submitted
- 17 Sep 2010
- Last updated
- 8 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective, Open-label, Single-arm Phase IIIb/IV Clinical Study on the Safety of Photodynamic Therapy With Porfimer Sodium for Injection for the Ablation of High-grade Dysplasia in Barrett's Esophagus
- ClinicalTrials.gov ID
- NCT01209013
- Acronym / sponsor ID
- Oedisse / MA-PO-PHOEST07-01
- Conditions
- Barrett Esophagus
- Keywords
- PDT, porfimer sodium, BE
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor cancelled the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pinnacle Biologics Inc.Industry (pharma, biotech, devices)
- First posted
- 24 Sep 2010 (estimated)
- 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.
Photodynamic therapy (PDT) uses a combination of a drug, porfimer sodium, and a light from a non heated laser. The activation of the drug is done by lighting of abnormal areas using a fiber optic device. The fiber optic device is a very fine fiber (like a fishing line) that permits transmission of light. The fiber optic device is inserted into a diffusing balloon device to ensure the good positioning of the fiber optic within the esophagus (food pipe). It is thought that the size and the flexibility of a new diffusing balloon device could improve the safety profile of the photodynamic treatment by reducing the risk of narrowing or closure of the food pipe (esophageal stenosis) sometimes occurring after treatment.
This research study will evaluate the safety and effectiveness of PDT with porfimer sodium using a new diffusing balloon device for light application in the removal of high-grade dysplasia (HGD, precancerous change in the food pipe tissue) in Barrett's esophagus (BE). This study will provide advanced knowledge about phototoxicity (reaction similar to sunburn) and esophageal stenosis, main risks with this therapy. It will involve 75 patients with HGD in BE across North America and Europe and will last between 13 and 16 weeks. In addition, concentrations of porfimer sodium in the esophageal tissue will be analyzed in a subgroup of patients.
Detailed description
Patients with biopsy-confirmed HGD in BE will be evaluated to confirm eligibility. Prior to enrollment, all inclusion and exclusion criteria will be verified. Medical procedures including demographic information, medical/surgical history, concurrent medical conditions, physical exam (including vital signs, body weight, height, and skin color), degree of difficulty in swallowing; electrocardiogram, chest X-ray, clinical laboratory testing, concomitant medication intake and other therapy uses will be collected.
All patients will receive one course of PDT consisting of an intravenous injection of 2.0 mg/kg of porfimer sodium over 3-5 minutes followed by one or two endoscopic laser light applications. The first laser light application will be performed within 40-50 hours using a new diffusing balloon catheter. The second laser light application (without a diffusing balloon catheter) will be performed within 96-120 hours on those areas showing an insufficient response to the first application. Follow-ups (Weeks 4 and 13) will include some or all of the following procedures: physical exam; vital signs evaluation; body weight; endoscopy; skin, degree of difficulty in swallowing and esophageal stenosis assessment; and clinical laboratory check. All patients will be asked general open questions about any occurrence of adverse events, change in concurrent medical conditions, use of adjunctive therapy/procedure, and intake of concomitant medication. All patients will undergo rigorous systematic endoscopic biopsy surveillance at Week 13 (final visit).
Tissue concentration of oligomers (component of porfimer sodium) in normal and abnormal esophageal tissues will be determined in a subgroup of 12 patients. These patients will provide esophageal tissue samples before the porfimer sodium injection and on four separate occasions after the injection (22-26 hour-, 40-50 hour-, 96-120 hour-intervals, and 13 weeks).
All patients will be followed for three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medlight PDT Balloon | Experimental | Device: Medlight PDT Balloon, Procedure: Endoscopy, Procedure: Endoscopy with biopsy, Procedure: Electrocardiogram, Procedure: Chest x-ray, Procedure: Blood collection, Procedure: Tissue sample collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients are males or females aged 18 or older.
- Patients have been diagnosed with biopsy-proven HGD in BE.
- Non-menopausal or non-surgically sterilized female patients must have a negative serum beta-HCG at the time of entry into the study.
- Non-menopausal or non-surgically sterilized female patients must use a medically acceptable form of birth control.
- Patients must sign an Informed Consent Form, which must comply with the ICH guidelines and local requirements.
Key exclusion criteria (17 listed)
- Patients who have previously received PDT for HGD in BE.
- Patients who have previously undergone radiation therapy to the chest.
- Patients with known porphyria or known hypersensitivity to porphyrins or any excipients of the porfimer sodium.
- Patients who have esophageal cancer or in whom esophageal cancer, lymph node involvement, or metastases cannot be ruled out based on the pathology report, endoscopic ultrasonography (EUS), computed tomography (CT) scan or other diagnostic methods used in current practice no more than 30 days prior to date of consent.
- Patients with any acute or chronic medical or psychological illnesses as judged clinically significant by the investigator to preclude PDT procedure.
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 |
|---|---|---|
| Medlight PDT BalloonMedlight PDT Balloon will be used once to apply the laser light treatment | Device | Medlight PDT Balloon |
| EndoscopyEndoscopy will be performed to confirm eligibility, apply photodynamic therapy, assess esophageal condition and effectiveness of the therapy | Procedure or surgery | Medlight PDT Balloon |
| Endoscopy with biopsyEndoscopy with collection of esophageal tissue will be performed at screening to confirm eligibility and at Week 13 (final visit) to assess effectiveness | Procedure or surgery | Medlight PDT Balloon |
| ElectrocardiogramResting electrocardiogram will be performed at screening (unless one has been performed within 30 days prior to screening) to measure heart function | Procedure or surgery | Medlight PDT Balloon |
| Chest x-rayA chest X-ray will be performed at screening (unless one has been performed within 90 days prior to screening) to provide several pictures of the chest to rule out any lung abnormalities | Procedure or surgery | Medlight PDT Balloon |
| Blood collectionBlood samples for laboratory tests will be taken to assess the overall condition | Procedure or surgery | Medlight PDT Balloon |
| Tissue sample collectionEsophageal tissue samples will be collected before the porfimer sodium injection and on four separate occasions after the injection (22-26 hour-, 40-50 hour-, 96-120 hour-intervals, and 13 weeks) to measure concentrations of oligomers in a subgroup of 12 patients. | Procedure or surgery | Medlight PDT Balloon |
Primary outcome
Incidence of phototoxicity reaction
Time frame: 3 months
Incidence of esophageal stenosis
Time frame: 3 months
3 secondary outcomes
Proportion of patients with complete ablation (removal) of high-grade dysplasia
Time frame: 3 months
Proportion of patients with adverse events as a measure of safety
Time frame: 3 months
Measure oligomer concentrations
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2012.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Medlight PDT Balloon, Endoscopy and Endoscopy with biopsy in people with Barrett Esophagus, run by Pinnacle Biologics Inc..
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 5 inclusion and 17 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: withdrawn, as of the sponsor's last update on 8 May 2012. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
Incidence of phototoxicity reaction (time frame: 3 months). The study lists 2 primary outcomes in all. 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 8 May 2012.