Ovarian CancerPhase 1NCT02000778
EC17 for Intraoperative Imaging in Occult Ovarian Cancer
A Phase 1 study testing EC17 in people with Ovarian Cancer, run by University of Pennsylvania at 1 site in United States.
Trial summary
The overall prevalence of Ovarian Cancer in the United States according to the US SEER Registry is 182,710 women. Ovarian cancer also has the highest mortality rate of the gynecological cancers. The overall five-year survival rate is 45% and for Stages III and IV it is only 20-25%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- EC17
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to 12 Nov 2014
- 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
- Female subjects 18 years of age and older
- Female subjects of childbearing potential or less than 2 years postmenopausal agree to receive a urinary or serum beta HCG test prior to subject enrollment. Documentation must be acquired for women of menopausal or post-menopausal status prior to subject enrollment if they are below the age of sixty (60).
- Primary diagnosis, or at high clinical suspicion, of primary ovarian cancer:
- Patient is scheduled to undergo laparotomy OR
- Patient is scheduled to undergo laparoscopy then pre-authorized laparotomy if cancer is found.
Who cannot join
- 1. Known sarcomatous histologies
- Recurrent ovarian cancer
- Known FR-alpha negative cancer
- Planned surgical approach via laparoscopy or robotic (no intention to perform laparotomy)
- History of anaphylactic reactions to Folate-FITC (EC17) or insects
- Pregnancy
Show all 13Show fewer
- Brain metastases
- Taking compounds that inhibit active transport of organic anions (probenecid)
- Hepatic impairment, as evidenced by greater than 3x the upper limit of normal (ULN) for ALT, AST, or total bilirubin (except for known cases of Gilbert's syndrome), or renal impairment, as evidenced by greater than 1.5x the ULN for BUN or creatinine
- Received study agent in another investigational drug or vaccine trial prior to surgery
- At-risk patient populations
- People who would easily be lost to follow up (ex: People who are homeless or alcohol dependent)
- Patients unable to participate in the consent process (children and neonates)
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Pilot & Feasibility Study of the Imaging Potential of EC17 in Subjects Undergoing Intraoperative Detection of Occult Ovarian Carcinoma
The overall prevalence of Ovarian Cancer in the United States according to the US SEER Registry is 182,710 women. Ovarian cancer also has the highest mortality rate of the gynecological cancers. The overall five-year survival rate is 45% and for Stages III and IV it is only 20-25%. The majority of these are aged 50 years or older, but a few girls less than 10 years of age have been diagnosed with ovarian cancer. This risk increases with age and decreases with numbers of pregnancies.
The prognosis for many carcinomas is dependent on the extent of surgical resection. At present, the ability to perform a complete resection with negative margins is limited by the investigator's ability to palpate and visualize the tumor and its borders. In many cases, a more radical resection than necessary is performed in order to provide assurance that negative margins are achieved. This approach may also increase complication rates, as well as short- and long-term morbidity. It is desirable to improve visualization of primary tumors and occult metastases in real time, during surgery. The use of fluorescent probes that recognize cancer-specific antigens, in conjunction with a clinical imaging system, is under investigation.
Read more
Ovarian cancer is a prototypic disease for this type of clinical imaging system called intra-operative imaging. Except in Stage IV, the tumors are confined to the pelvis or abdomen and typically involve extensions or implants onto pelvic or abdominal organs or membranes. Tumor debulking surgery is common early in the disease process as many of the tumors can be identified by appearance or feel in the skilled surgeon's hands. The major problems are that tumors can be diffuse and numerous, of various sizes, and often not readily visible in the surgical field.
Over 90-95% of serous ovarian cancers express folate receptor (FR)-alpha, making this receptor an ideal target for marking most ovarian cancers. Folate is the prototypic agonist at the FR-alpha with potential uses for imaging and targeted therapeutic strategies.Chemotherapy does not affect FR-alpha expression in ovarian cancer specimens examined by immunohistochemistry, so prior treatment is unlikely to affect utility of FR-alpha agonists as imaging or therapeutic agents.
- Conditions
- Ovarian Cancer
- Being tested
- EC17
- Keywords
- Occult Ovarian Carcinoma
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EC17Drug
Also called Folate-FITC
| Study group | Role | What they receive |
|---|---|---|
| EC17 Injection Group | Experimental | The group will receive a single dose of EC17, infused over 10 minutes, prior to surgery. Then, during surgery, the EC-17 will be imaged with a camera that the investigators have developed. Receives: Drug: EC17 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ability of EC17 and the imaging system to detect FRA positive tumors during surgery conducted 2-4 hours post EC-17 administration.
Measured: Within two to four hours of injection of EC17
Secondary outcomes (1)
The number of participants that will have an adverse reaction to the EC17
Measured: Day 1-Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startNov 2013
- Primary completion12 Nov 2014
- Study completion12 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sunil Singhal, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02000778
- Sponsor's protocol ID
- 818533
- Other IDs
- 818533 [UPenn IRB Protocol #]
- Status last verified
- Mar 2017
- First submitted
- 26 Nov 2013
- Last updated
- 4 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot & Feasibility Study of the Imaging Potential of EC17 in Subjects Undergoing Intraoperative Detection of Occult Ovarian Carcinoma
- ClinicalTrials.gov ID
- NCT02000778
- Acronym / sponsor ID
- 818533
- Conditions
- Ovarian Cancer
- Keywords
- Occult Ovarian Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- 12 Nov 2014 (actual)
- Study completion
- 12 Nov 2014 (actual)
- First posted
- 4 Dec 2013 (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.
The overall prevalence of Ovarian Cancer in the United States according to the US SEER Registry is 182,710 women. Ovarian cancer also has the highest mortality rate of the gynecological cancers. The overall five-year survival rate is 45% and for Stages III and IV it is only 20-25%. The majority of these are aged 50 years or older, but a few girls less than 10 years of age have been diagnosed with ovarian cancer. This risk increases with age and decreases with numbers of pregnancies.
The prognosis for many carcinomas is dependent on the extent of surgical resection. At present, the ability to perform a complete resection with negative margins is limited by the investigator's ability to palpate and visualize the tumor and its borders. In many cases, a more radical resection than necessary is performed in order to provide assurance that negative margins are achieved. This approach may also increase complication rates, as well as short- and long-term morbidity. It is desirable to improve visualization of primary tumors and occult metastases in real time, during surgery. The use of fluorescent probes that recognize cancer-specific antigens, in conjunction with a clinical imaging system, is under investigation.
Ovarian cancer is a prototypic disease for this type of clinical imaging system called intra-operative imaging. Except in Stage IV, the tumors are confined to the pelvis or abdomen and typically involve extensions or implants onto pelvic or abdominal organs or membranes. Tumor debulking surgery is common early in the disease process as many of the tumors can be identified by appearance or feel in the skilled surgeon's hands. The major problems are that tumors can be diffuse and numerous, of various sizes, and often not readily visible in the surgical field.
Over 90-95% of serous ovarian cancers express folate receptor (FR)-alpha, making this receptor an ideal target for marking most ovarian cancers. Folate is the prototypic agonist at the FR-alpha with potential uses for imaging and targeted therapeutic strategies.Chemotherapy does not affect FR-alpha expression in ovarian cancer specimens examined by immunohistochemistry, so prior treatment is unlikely to affect utility of FR-alpha agonists as imaging or therapeutic agents.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EC17 Injection Group | Experimental | Drug: EC17The group will receive a single dose of EC17, infused over 10 minutes, prior to surgery. Then, during surgery, the EC-17 will be imaged with a camera that the investigators have developed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female subjects 18 years of age and older
- Female subjects of childbearing potential or less than 2 years postmenopausal agree to receive a urinary or serum beta HCG test prior to subject enrollment. Documentation must be acquired for women of menopausal or post-menopausal status prior to subject enrollment if they are below the age of sixty (60).
- Primary diagnosis, or at high clinical suspicion, of primary ovarian cancer:
Key exclusion criteria (13 listed)
- 1. Known sarcomatous histologies
- Recurrent ovarian cancer
- Known FR-alpha negative cancer
- Planned surgical approach via laparoscopy or robotic (no intention to perform laparotomy)
- History of anaphylactic reactions to Folate-FITC (EC17) or insects
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 |
|---|---|---|
| EC17Also: Folate-FITC | Drug | EC17 Injection Group |
Primary outcome
The ability of EC17 and the imaging system to detect FRA positive tumors during surgery conducted 2-4 hours post EC-17 administration.
Time frame: Within two to four hours of injection of EC17
1 secondary outcome
The number of participants that will have an adverse reaction to the EC17
Time frame: Day 1-Day 30
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 4 Jun 2018.
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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.
Sunil Singhal principal investigator
University of Pennsylvania
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 EC17 in people with Ovarian Cancer, run by University of Pennsylvania 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 5 inclusion and 13 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 4 Jun 2018. 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?
The ability of EC17 and the imaging system to detect FRA positive tumors during surgery conducted 2-4 hours post EC-17 administration. (time frame: Within two to four hours of injection of EC17). 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 4 Jun 2018.