NeoplasmsPhase 1NCT02602119
Intraoperative Imaging of Pulmonary Nodules by OTL38
A Phase 1 study testing OTL38 in people with Neoplasms, run by University of Pennsylvania at 1 site in United States.
Trial summary
The primary end-point of the study is to determine the sensitivity of OTL in identifying lung nodules when excited by an imaging probe. Investigators intend to enroll 300 lung cancer patients in this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- OTL38
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to 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
- Adult patients over 18 years of age
- Patients presenting with a lung or pleural nodule or mass presumed to be resectable on pre- operative assessment
- Good operative candidate
- 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 within 72 hours of surgery
- Patients with a history of anaphylactic reactions to OTL38
- Patients with a known allergy to Benadryl
- At-risk patient populations:
- Homeless patients
- Patients with drug or alcohol dependence
- Children and neonates
- Patients unable to participate in the consent process.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
The primary end-point of the study is to determine the sensitivity of OTL in identifying lung nodules when excited by an imaging probe. Investigators intend to enroll 300 lung cancer patients in this study. The study is focusing on patients presenting with suspected malignancies of the lung and pleura who are considered to be good surgical candidates.
Read the detailed description
According to the World Health Organization, lung cancer is the most common cause of cancer-related death in men and women, and is responsible for 1.5 million deaths worldwide annually as of 2012. Surgery remains the best option for patients presenting with operable Stage I or II cancers, however the five year survival rate for these candidates remains at a dismal 73% for Stage I and 53% for Stage II. The high rates of local recurrence suggest that surgeons are unable to completely detect and remove primary tumor nodules in a satisfactory manner as well as lingering metastases in sentinel lymph nodes. By ensuring a negative margin through imaging during surgery it would be possible for the investigators to improve the rates of recurrence free patients and thus overall survival.
Thoracic malignancies are the ideal disease to investigate intra-operative imaging. Over 85% of lung and pleural malignancies express folate receptor alpha (FRA), therefore making folate receptors (FR) the ideal targets for imaging agents. While folate will initially distribute to all cells, redistribution, metabolism, and excretion will eliminate most of this agent from healthy tissues within hours. Tumor cells that over express FRα will retain folate and any fluorescent labeled folate conjugate and internalize this. It is important to note that FRA is expressed only in the proximal tubules of the kidneys, activated macrophages, and in the choroidal plexus. However, the fluorescence signal in the kidneys is expected to be significantly lower than the tumor tissues. Thus, the false positive detection rate is expected to be extremely low.
The investigators have conducted a Phase I clinical trial with folate-FITC in 50 patients with lung cancer. In the study at UPenn, the investigators had no adverse events. The investigators had excellent sensitivity and specificity with this technique with only grade 1 side effects (allergic reaction). All side effects reversed when the injection was halted. This study confirmed that FRA is a reasonable target for lung cancer.
On Target Laboratories, LLC has developed OTL38. Compared with some of the existing fluorescent imaging agents, OTL38 is associated with less auto-fluorescence due to its near-IR excitation wavelength and can be seen through blood and tissues up to 1.5 cm thickness. Thus, in this study, the investigator's goal has changed from the folate-FITC formulation to the OTL38 formulation. The fluorophore component of the drug is new, whereas the target and design of the study remain unchanged.
- Conditions
- Neoplasms
- Being tested
- OTL38
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTL38Drug
Infusion of OTL38 prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| OTL38 | Experimental | Dosage calculated by weight of individual Receives: Drug: OTL38 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of the imaging system to detect the expression of the OTL38 in the nodule/mass (i.e tumor) and discern the uptake of the dye by the tumor.
Detected with imaging probe.
Measured: 5 years
Microscopic examination and immunohistochemistry of tumor
Performed by a pathologist. This will allow investigators to compare pathology results with video images taken by imaging probe to calculate false positive (i.e., identification of non FRA-positive tumors) rates of OTL38.
Measured: 5 years
Secondary outcomes (1)
Incidence rates of all AEs, treatment-emergent adverse events (TEAEs) and adverse device events (ADEs) from time of OTL38 administration through participants' first, post-operative appointment with surgeon.
Measured: 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 Nov 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2022
- Study completionMay 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sunil Singhal, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602119
- Sponsor's protocol ID
- 822153
- Status last verified
- Jun 2022
- First submitted
- 2 Nov 2015
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Imaging of Pulmonary Nodules by OTL38
- ClinicalTrials.gov ID
- NCT02602119
- Acronym / sponsor ID
- 822153
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- May 2022 (actual)
- Study completion
- May 2022 (actual)
- First posted
- 11 Nov 2015 (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 primary end-point of the study is to determine the sensitivity of OTL in identifying lung nodules when excited by an imaging probe. Investigators intend to enroll 300 lung cancer patients in this study. The study is focusing on patients presenting with suspected malignancies of the lung and pleura who are considered to be good surgical candidates.
Detailed description
According to the World Health Organization, lung cancer is the most common cause of cancer-related death in men and women, and is responsible for 1.5 million deaths worldwide annually as of 2012. Surgery remains the best option for patients presenting with operable Stage I or II cancers, however the five year survival rate for these candidates remains at a dismal 73% for Stage I and 53% for Stage II. The high rates of local recurrence suggest that surgeons are unable to completely detect and remove primary tumor nodules in a satisfactory manner as well as lingering metastases in sentinel lymph nodes. By ensuring a negative margin through imaging during surgery it would be possible for the investigators to improve the rates of recurrence free patients and thus overall survival.
Thoracic malignancies are the ideal disease to investigate intra-operative imaging. Over 85% of lung and pleural malignancies express folate receptor alpha (FRA), therefore making folate receptors (FR) the ideal targets for imaging agents. While folate will initially distribute to all cells, redistribution, metabolism, and excretion will eliminate most of this agent from healthy tissues within hours. Tumor cells that over express FRα will retain folate and any fluorescent labeled folate conjugate and internalize this. It is important to note that FRA is expressed only in the proximal tubules of the kidneys, activated macrophages, and in the choroidal plexus. However, the fluorescence signal in the kidneys is expected to be significantly lower than the tumor tissues. Thus, the false positive detection rate is expected to be extremely low.
The investigators have conducted a Phase I clinical trial with folate-FITC in 50 patients with lung cancer. In the study at UPenn, the investigators had no adverse events. The investigators had excellent sensitivity and specificity with this technique with only grade 1 side effects (allergic reaction). All side effects reversed when the injection was halted. This study confirmed that FRA is a reasonable target for lung cancer.
On Target Laboratories, LLC has developed OTL38. Compared with some of the existing fluorescent imaging agents, OTL38 is associated with less auto-fluorescence due to its near-IR excitation wavelength and can be seen through blood and tissues up to 1.5 cm thickness. Thus, in this study, the investigator's goal has changed from the folate-FITC formulation to the OTL38 formulation. The fluorophore component of the drug is new, whereas the target and design of the study remain unchanged.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OTL38 | Experimental | Drug: OTL38Dosage calculated by weight of individual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients over 18 years of age
- Patients presenting with a lung or pleural nodule or mass presumed to be resectable on pre- operative assessment
- Good operative candidate
- Subject capable of giving informed consent and participating in the process of consent.
Key exclusion criteria (8 listed)
- Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery
- Patients with a history of anaphylactic reactions to OTL38
- Patients with a known allergy to Benadryl
- At-risk patient populations:
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 |
|---|---|---|
| OTL38Infusion of OTL38 prior to surgery | Drug | OTL38 |
Primary outcome
Ability of the imaging system to detect the expression of the OTL38 in the nodule/mass (i.e tumor) and discern the uptake of the dye by the tumor.
Time frame: 5 years
Detected with imaging probe.
Microscopic examination and immunohistochemistry of tumor
Time frame: 5 years
Performed by a pathologist. This will allow investigators to compare pathology results with video images taken by imaging probe to calculate false positive (i.e., identification of non FRA-positive tumors) rates of OTL38.
1 secondary outcome
Incidence rates of all AEs, treatment-emergent adverse events (TEAEs) and adverse device events (ADEs) from time of OTL38 administration through participants' first, post-operative appointment with surgeon.
Time frame: 5 years
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 28 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, MD 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 in people with Neoplasms, 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 4 inclusion and 8 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 28 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 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?
Ability of the imaging system to detect the expression of the OTL38 in the nodule/mass (i.e tumor) and discern the uptake of the dye by the tumor. (time frame: 5 years). 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 28 Jun 2022.