Ovarian CancerPhase 1NCT04941378
OTL38 Injection (OTL38) for Intra-Operative Imaging of Folate Receptor Positive Ovarian Cancer
A Phase 1 study testing OTL38 and intraoperative imaging camera system in people with Ovarian Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
The primary objective of the study is to compare the performance of different camera imaging systems in assessing the positive predictive values and sensitivity of OTL38 to detect folate positive ovarian cancer cancers using the gold standard of pathologic review. 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?
- OTL38 and intraoperative imaging camera system
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2022to 28 May 2022
- 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 patients > 18 years of age
- Have a primary diagnosis, or at high clinical suspicion, of primary ovarian cancer (of epithelial type), planned for primary surgical cytoreduction, interval debulking, or have recurrent ovarian cancer
- Good operative candidate as determined by clinical presentation and laboratory assessments
- Subject capable of giving informed consent and participating in the process of consent.
Who cannot join
- Pregnant women as determined by urinary or serum beta hCG.
- Patients with a history of allergy to any of the components of OTL38, including folic acid
- Known FR-negative ovarian cancer
- Patients with a known allergy to Benadryl
- Previous exposure to OTL38
- Vulnerable populations: the homeless, prisoners or not capable of participating in the consent process
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Pilot, Single Dose, Open-Label Study of OTL38 Injection (OTL38) for Intra-Operative Imaging of Folate Receptor Positive Ovarian Cancer
The primary objective of the study is to compare the performance of different camera imaging systems in assessing the positive predictive values and sensitivity of OTL38 to detect folate positive ovarian cancer cancers using the gold standard of pathologic review.
Read the detailed description
Patients will be seen in the Ovarian Cancer Clinic. Patients that have or are suspected to have ovarian cancer, and are candidates for debulking surgery based on the clinician evaluation, may be considered candidates for this study. As over 90% of ovarian epithelial cancers express folate receptor, we would expect a high percentage of these patients scheduled for surgery, to have eligible cancer types for entry into the study. These patients will be prospectively consented to participate in this trial. There will be no randomization or control group and only patients previously scheduled to undergo surgery will be eligible to participate. We anticipate a 2-year period will be necessary to reach our accrual goal of up to 10 patients.
After obtaining informed consent, patients will receive a one-time dose of 0.025 mg/kg of OTL38, infused over approximately 60 minutes and completed at least 1 hour prior to intraoperative imaging. As a prophylactic measure, we recommend 25mg of IV Benadryl to the patient prior to the infusion of OTL38 to decrease the possibility of a hypersensitivity reaction.
The duration of surgical procedures to resect ovarian cancers varies substantially, anywhere from 3- 8 hours or more. During the phase 2 study, the median time spent imaging the patients with a single camera was 14 minutes. Utilizing two cameras to complete imaging would not overly increase the duration of time patients spend under anesthesia. However, there is a chance that being under anesthesia for the additional 25-35 minutes could put the patient at an increased risk of having of a common side effect associated with anesthesia. These common side effects include, but are not limited to: nausea and vomiting after surgery, sore throat and hoarseness, shivering/chills, confusion, and muscle aches
- Conditions
- Ovarian Cancer
- Being tested
- OTL38, intraoperative imaging camera system
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTL38Drug
One time infusion of OTL38
intraoperative imaging camera systemDevice
intraoperative imaging camera system
| Study group | Role | What they receive |
|---|---|---|
| OTL 38 | Experimental | The study drug in question is an Investigational New Drug (IND), folate analog ligand conjugated with an indole cyanine green-like dye called OTL38. There will be a single dose of 0.025 mg/kg for intravenous injection over approximately 60 minutes, completed at least 1 hour prior to intraoperative imaging Receives: Drug: OTL38; Device: intraoperative imaging camera system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the performance of different camera imaging systems in assessing the positive predictive values
The primary objective of the study is to compare the performance of different camera imaging systems in assessing the sensitivity and positive predictive value of OTL38 to detect folate positive ovarian cancers using the gold standard of pathologic review.
Measured: Up to 4 weeks post surgery (completion of post-operative follow-up visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start28 May 2022
- Primary completion28 May 2022
- Study completion28 May 2022
Why it stopped: Due to sponsor request
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 Abramson Cancer Center at Penn MedicineThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sunil Singhal, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941378
- Sponsor's protocol ID
- UPCC 11818
- Status last verified
- Jun 2022
- First submitted
- 21 Jun 2021
- Last updated
- 27 Jun 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Single Dose, Open-Label Study of OTL38 Injection (OTL38) for Intra-Operative Imaging of Folate Receptor Positive Ovarian Cancer
- ClinicalTrials.gov ID
- NCT04941378
- Acronym / sponsor ID
- UPCC 11818
- Conditions
- Ovarian Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to sponsor request
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 28 May 2022 (actual)
- Primary completion
- 28 May 2022 (actual)
- Study completion
- 28 May 2022 (actual)
- First posted
- 28 Jun 2021 (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.
The primary objective of the study is to compare the performance of different camera imaging systems in assessing the positive predictive values and sensitivity of OTL38 to detect folate positive ovarian cancer cancers using the gold standard of pathologic review.
Detailed description
Patients will be seen in the Ovarian Cancer Clinic. Patients that have or are suspected to have ovarian cancer, and are candidates for debulking surgery based on the clinician evaluation, may be considered candidates for this study. As over 90% of ovarian epithelial cancers express folate receptor, we would expect a high percentage of these patients scheduled for surgery, to have eligible cancer types for entry into the study. These patients will be prospectively consented to participate in this trial. There will be no randomization or control group and only patients previously scheduled to undergo surgery will be eligible to participate. We anticipate a 2-year period will be necessary to reach our accrual goal of up to 10 patients.
After obtaining informed consent, patients will receive a one-time dose of 0.025 mg/kg of OTL38, infused over approximately 60 minutes and completed at least 1 hour prior to intraoperative imaging. As a prophylactic measure, we recommend 25mg of IV Benadryl to the patient prior to the infusion of OTL38 to decrease the possibility of a hypersensitivity reaction.
The duration of surgical procedures to resect ovarian cancers varies substantially, anywhere from 3- 8 hours or more. During the phase 2 study, the median time spent imaging the patients with a single camera was 14 minutes. Utilizing two cameras to complete imaging would not overly increase the duration of time patients spend under anesthesia. However, there is a chance that being under anesthesia for the additional 25-35 minutes could put the patient at an increased risk of having of a common side effect associated with anesthesia. These common side effects include, but are not limited to: nausea and vomiting after surgery, sore throat and hoarseness, shivering/chills, confusion, and muscle aches
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OTL 38 | Experimental | Drug: OTL38, Device: intraoperative imaging camera systemThe study drug in question is an Investigational New Drug (IND), folate analog ligand conjugated with an indole cyanine green-like dye called OTL38. There will be a single dose of 0.025 mg/kg for intravenous injection over approximately 60 minutes, completed at least 1 hour prior to intraoperative imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patients > 18 years of age
- Have a primary diagnosis, or at high clinical suspicion, of primary ovarian cancer (of epithelial type), planned for primary surgical cytoreduction, interval debulking, or have recurrent ovarian cancer
- Good operative candidate as determined by clinical presentation and laboratory assessments
- Subject capable of giving informed consent and participating in the process of consent.
Key exclusion criteria (6 listed)
- Pregnant women as determined by urinary or serum beta hCG.
- Patients with a history of allergy to any of the components of OTL38, including folic acid
- Known FR-negative ovarian cancer
- Patients with a known allergy to Benadryl
- Previous exposure to OTL38
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 |
|---|---|---|
| OTL38One time infusion of OTL38 | Drug | OTL 38 |
| intraoperative imaging camera systemintraoperative imaging camera system | Device | OTL 38 |
Primary outcome
Compare the performance of different camera imaging systems in assessing the positive predictive values
Time frame: Up to 4 weeks post surgery (completion of post-operative follow-up visit)
The primary objective of the study is to compare the performance of different camera imaging systems in assessing the sensitivity and positive predictive value of OTL38 to detect folate positive ovarian cancers using the gold standard of pathologic review.
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 27 Jun 2022.
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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 OTL38 and intraoperative imaging camera system in people with Ovarian Cancer, run by Abramson Cancer Center at Penn Medicine 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 4 inclusion and 6 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 27 Jun 2022. 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 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?
Compare the performance of different camera imaging systems in assessing the positive predictive values (time frame: Up to 4 weeks post surgery (completion of post-operative follow-up visit)). 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 27 Jun 2022.