Fallopian Tube CarcinomaEarly Phase 1NCT03297489
Intravital Microscopy in Evaluating Patients With Primary Peritoneal, Fallopian Tube, or Stage IA-IV Ovarian Cancer
A Early Phase 1 study testing Diagnostic Microscopy, Fluorescein Sodium Injection and Laboratory Biomarker Analysis in people with Fallopian Tube Carcinoma and Primary Peritoneal Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This pilot clinical trial studies how well intravital microscopy works in evaluating patients with primary peritoneal, fallopian tube, or stage IA-IV ovarian cancer. Intravital microscopic evaluation of tumor blood vessels, blood flow, immune cell interactions, and drug uptake may be eventually visualized and may lead… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma, Stage I Ovarian Cancer
- What is being tested?
- Diagnostic Microscopy, Fluorescein Sodium Injection and Laboratory Biomarker Analysis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2017to 15 Feb 2021
- Phase
- Early 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
- Suspicion of gynecological malignancy that requires a standard of care surgical resection in the operating room;
- Have measurable lesion in the pelvis or abdomen, at a minimum of 0.5 cm in diameter on standard of care pre operative imaging studies (CT, MRI or PET scan),
- Subject or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
- Serum Creatinine <= 1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance ≥ 60 mL/min for participant with creatinine levels > 1.5 X institutional ULN (using Cockcroft-Gault Equation), GFR can also be used in place of creatinine or CrCl.
Who cannot join
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Any known allergy or prior reaction to fluorescein
- Nursing female subjects
- Liver dysfunction; normal liver function defined as total bilirubin within normal institutional limits and aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normal
- Any condition which in the Investigator's opinion deems the subject an unsuitable candidate to undergo observational study (may also include preoperative testing results including electrocardiography (EKG), chest x-ray, or pulmonary function tests that preclude a wide excision in the operating room)
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: A Pilot Study of Feasibility of Performing Intravital Microscopy in Patients With Ovarian, Primary Peritoneal or Fallopian Tube Cancer
This pilot clinical trial studies how well intravital microscopy works in evaluating patients with primary peritoneal, fallopian tube, or stage IA-IV ovarian cancer. Intravital microscopic evaluation of tumor blood vessels, blood flow, immune cell interactions, and drug uptake may be eventually visualized and may lead to valuable prognostic information.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of performing intravital microscopy on accessible human ovarian, primary peritoneal and fallopian tube cancers during their standard course of treatment (i.e., surgical debulking).
SECONDARY OBJECTIVES:
- To determine the blood flow velocity of the tumor vessels and tissue penetration of fluorescein as a marker of tumor vessel permeability.
OUTLINE:
Patients receive fluorescein sodium injection intravenously (IV). Patients also undergo observation of primary and metastatic tumors via microscopy over 15-20 minutes during the course of standard of care surgery.
After completion of study, patients are followed up for 30 days, at 1-3 weeks, and then up to 2 years.
- Conditions
- Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma, Stage I Ovarian Cancer, Stage IA Ovarian Cancer, Stage IB Ovarian Cancer, Stage IC Ovarian Cancer
- Being tested
- Diagnostic Microscopy, Fluorescein Sodium Injection, Laboratory Biomarker Analysis
- Medical subject headings
- Fallopian Tube Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic MicroscopyProcedure or surgery
Undergo observation via intravital microscopy
Fluorescein Sodium InjectionDrug
Also called AK-Fluor, Fluorescite
Given IV
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (intravital microscopy) | Experimental | Patients receive fluorescein sodium injection IV. Patients also undergo observation of primary and metastatic tumors via microscopy over 15-20 minutes during the course of standard of care surgery. Receives: Procedure: Diagnostic Microscopy; Drug: Fluorescein Sodium Injection; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluorescein within the tumor vessels
Will visualize fluorescein within the tumor vessels.
Measured: Up to 2 years
Identification of tumor vessels
Will identify tumor vessels.
Measured: Up to 2 years
Tumor vessel diameter
Will measure tumor vessel diameters.
Measured: Up to 2 years
Vessel density
Will determine vessel density per 10 x field.
Measured: Up to 2 years
Secondary outcomes (2)
Blood flow velocity of the tumor vessels
Will assess the ability to measure the blood flow velocity of the tumor vessels.
Measured: Up to 2 years
Tissue penetration of fluorescein
Will measure tissue penetration of fluorescein as a marker of tumor vessel permeability.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start6 Nov 2017
- Primary completion15 Feb 2021
- Study completion15 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fallopian Tube CarcinomaStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emese Zsiros, MD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297489
- Sponsor's protocol ID
- I 43717
- Other IDs
- NCI-2017-01459, I 43717
- Status last verified
- Oct 2021
- First submitted
- 26 Sep 2017
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Feasibility of Performing Intravital Microscopy in Patients With Ovarian, Primary Peritoneal or Fallopian Tube Cancer
- ClinicalTrials.gov ID
- NCT03297489
- Acronym / sponsor ID
- I 43717
- Conditions
- Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma, Stage I Ovarian Cancer, Stage IA Ovarian Cancer, Stage IB Ovarian Cancer, Stage IC Ovarian Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 29 Sep 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 pilot clinical trial studies how well intravital microscopy works in evaluating patients with primary peritoneal, fallopian tube, or stage IA-IV ovarian cancer. Intravital microscopic evaluation of tumor blood vessels, blood flow, immune cell interactions, and drug uptake may be eventually visualized and may lead to valuable prognostic information.
Detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of performing intravital microscopy on accessible human ovarian, primary peritoneal and fallopian tube cancers during their standard course of treatment (i.e., surgical debulking).
SECONDARY OBJECTIVES:
- To determine the blood flow velocity of the tumor vessels and tissue penetration of fluorescein as a marker of tumor vessel permeability.
OUTLINE:
Patients receive fluorescein sodium injection intravenously (IV). Patients also undergo observation of primary and metastatic tumors via microscopy over 15-20 minutes during the course of standard of care surgery.
After completion of study, patients are followed up for 30 days, at 1-3 weeks, and then up to 2 years.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (intravital microscopy) | Experimental | Procedure: Diagnostic Microscopy, Drug: Fluorescein Sodium Injection, Other: Laboratory Biomarker AnalysisPatients receive fluorescein sodium injection IV. Patients also undergo observation of primary and metastatic tumors via microscopy over 15-20 minutes during the course of standard of care surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
- Suspicion of gynecological malignancy that requires a standard of care surgical resection in the operating room;
- Have measurable lesion in the pelvis or abdomen, at a minimum of 0.5 cm in diameter on standard of care pre operative imaging studies (CT, MRI or PET scan),
- Subject or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
- Serum Creatinine <= 1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance ≥ 60 mL/min for participant with creatinine levels > 1.5 X institutional ULN (using Cockcroft-Gault Equation), GFR can also be used in place of creatinine or CrCl.
Key exclusion criteria (5 listed)
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Any known allergy or prior reaction to fluorescein
- Nursing female subjects
- Liver dysfunction; normal liver function defined as total bilirubin within normal institutional limits and aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normal
- Any condition which in the Investigator's opinion deems the subject an unsuitable candidate to undergo observational study (may also include preoperative testing results including electrocardiography (EKG), chest x-ray, or pulmonary function tests that preclude a wide excision in the operating room)
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 |
|---|---|---|
| Diagnostic MicroscopyUndergo observation via intravital microscopy | Procedure or surgery | Diagnostic (intravital microscopy) |
| Fluorescein Sodium InjectionAlso: AK-Fluor, FluoresciteGiven IV | Drug | Diagnostic (intravital microscopy) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Diagnostic (intravital microscopy) |
Primary outcome
Fluorescein within the tumor vessels
Time frame: Up to 2 years
Will visualize fluorescein within the tumor vessels.
Identification of tumor vessels
Time frame: Up to 2 years
Will identify tumor vessels.
Tumor vessel diameter
Time frame: Up to 2 years
Will measure tumor vessel diameters.
Vessel density
Time frame: Up to 2 years
Will determine vessel density per 10 x field.
2 secondary outcomes
Blood flow velocity of the tumor vessels
Time frame: Up to 2 years
Tissue penetration of fluorescein
Time frame: Up to 2 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 6 Oct 2021.
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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.
Emese Zsiros, MD principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Diagnostic Microscopy, Fluorescein Sodium Injection and Laboratory Biomarker Analysis in people with Fallopian Tube Carcinoma and Primary Peritoneal Carcinoma, run by Roswell Park Cancer Institute 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 5 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 6 Oct 2021. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Fluorescein within the tumor vessels (time frame: Up to 2 years). The study lists 4 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 6 Oct 2021.