NevusNCT01993654
In Vivo Confocal Microscopy Study of Pigmented Conjunctival Lesions
An observational study of Nevus and Racial Melanosis, run by Massachusetts Eye and Ear Infirmary at 3 sites in United States.
Trial summary
This study aims to validate the use of laser in vivo confocal microscopy as an early diagnostic and differentiation tool of pigmented conjunctival lesions, evaluate the efficacy of in vivo confocal microscopy for follow-up (as a visualizing tool) after tumor resection for early detection of tumor recurrence, and to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nevus, Racial Melanosis, Primary Acquired Melanosis
- What is being tested?
- HRT III with Non-Contact Cornea Rostock Module
- Type of treatment
- Surgery or procedure
- How many people
- 17 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2011to Jul 2015
- Phase
- Observational
- 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
Study population: Male or female patients over the age of 18 and belonging to one of the following groups will be recruited for this study. Group 1: Nevus Group 2: Racial melanosis Group 3: Primary Acquired Melanosis Group 4: Malignant Melanoma of the Conjunctiva Group 5: Normal Subjects with no pigmented lesions Normal subjects will be recruited from patients normally seen during clinic for cataract evaluations. Groups 1-4 will be identified by the investigators at MEEI and other 2 sites as potential study subjects during regular clinic visits.
Who may be able to join
- Age over 18 years
- The ability to provide informed consent for enrollment in the study
- Diagnosis of conjunctival nevus (Group 1 only)
- Diagnosis of racial melanosis (Group 2 only)
- Diagnosis or suspicion of primary acquired melanosis (PAM), scheduled for biopsy (Group 3 only)
- Diagnosis of possible MM scheduled for biopsy (Group 4 only)
Show all 11Show fewer
- Confirmed diagnosis of MM based upon clinical and histopathological findings, and have already undergone resection(Group 4 only)
- Confirmed diagnosis of MM recurrence based upon clinical and histopathological findings(Group 4 only)
- Clear cornea (Group 5 only)
- No conjunctival lesions or recent conjunctival diseases(Group 5 only)
- No recent chemotherapy or radiotherapy(Group 5 only)
Who cannot join
- History of previous ocular surgery within last 3 months
- History of inflammatory eye diseases within last 3 months
- Current or history of glaucoma disease and on glaucoma medication
- Contact lens use within last 3 months
- Physical inability to cooperate for confocal microscopy
- Prior history of infectious keratitis within 3 months
Show all 11Show fewer
- Suspicion for PAM or malignant melanoma (MM)(Groups 1,2,3)
- History of PAM or MM(Groups 1,2,3)
- Histopathology not confirmatory for MM (group 4 only)
- History of other ocular carcinoma or any recent ocular topical chemotherapy or radiotherapy (Group 5 only)
- History of cancer elsewhere in the body which is currently under systemic chemotherapy (group 5 only)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts Eye & Ear Infirmary
Boston, Massachusetts, 02114
MD Anderson Cancer Center
Houston, Texas, 77030
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
About this study
This study aims to validate the use of laser in vivo confocal microscopy as an early diagnostic and differentiation tool of pigmented conjunctival lesions, evaluate the efficacy of in vivo confocal microscopy for follow-up (as a visualizing tool) after tumor resection for early detection of tumor recurrence, and to evaluate the use of in vivo confocal microscopy in evaluation of response to treatment. The modified technique with Heidelberg Retina Tomography (HRT) confocal microscopy and anterior segment optical coherence tomography (OCT) are non-invasive, no-touch, imaging techniques that may help in differentiation of benign lesions like nevi or racial melanosis, from malignant lesions like primary acquired melanosis and malignant melanomas. The OCT will potentially allow to estimate tumor depth in vivo as preliminary studies have shown.
Read the detailed description
Conjunctival melanoma is a potentially lethal neoplasm, with an average 10-year mortality rate of 30%, and 15-year mortality rate of 45%. This condition occurs mainly in the white population, with rare reports in black and other non-white populations. Recent studies have indicated that like cutaneous melanoma, the incidence of conjunctival melanoma is increasing.
Conjunctival Malignant Melanoma (MM) is also currently diagnosed based upon clinical grounds, through observation of the growth of the suspected lesions over regular intervals of time. Unfortunately simple slit lamp examination is currently the only clinical diagnostic visual instrument available in medical practice, and the early diagnosis of MM by slit-lamp examination is still rather poor. Further the diagnosis of invasive conjunctival MM is currently established by conjunctival excisional biopsy and defined by the invasion of the underlying substantia propria of the conjunctiva by atypical tumor cells, especially when there is loss of the maturation. Regarding the management of malignant melanoma, unfortunately the extensive horizontal and even vertical growth of this neoplasm does not always lend itself to simple excision leading to exenteration. As a vision-sparing alternative, local excision with cryotherapy has become the treatment of choice. Long-term follow-up has shown that local recurrences are common. More recently, topical chemotherapy with mitomycin C (MMC) has been used to treat cases with extensive PAM with atypia , because the pigmented margin is used as a guide for most conservative treatments, the tumor's edge may be missed.
Recurrent conjunctival MM often presents as an amelanotic mass and may be mistaken for pyogenic granuloma in a patient who has had multiple previous excisions of conjunctival MM, even though the original tumor may have been pigmented. Because of the lack of pigment, these tumors can remain unrecognized and progressively enlarge, especially if the patient has had previous surgery and conjunctival scarring. In addition, the tumor margins of recurrent amelanotic conjunctival MM may be indistinct. These factors can lead to delayed recognition and the unnecessary need for exenteration. Despite these radical procedures, which usually lead to loss of vision or the eye, these patients have been shown to have a poor survival rate, suggesting that metastasis has already occurred at the time of treatment. This confirms that the extent of the disease at diagnosis is the most important factor to determine the outcome. Recurrence of conjunctival MM is reported at 26% at 5 years and, 51% at 10 years.
MM of the conjunctival represents one of the greatest challenges in early or preventive detection. Whereas surgical excision in early stages of tumor development is almost always curative, delayed recognition puts the patient at risk of destructive growth and death once the tumor has progressed to competence for metastasis. Accurate diagnosis of pigmented lesions of the conjunctiva such as nevi, primary, and secondary acquired melanosis and MM present a challenge to both the ophthalmologist and the pathologist. It is not possible clinically to distinguish between PAM with and without atypia. The ability to detect early MM remains of paramount importance in our efforts to curtail deaths related to this malignancy. The implementation and utilization of in vivo imaging technologies in clinical practice would enhance our ability to detect MM while this cancer is in its early stages and curable. Further, accurate assessment of therapeutic tumor response is critical for evaluation of chemotherapy results in patients, and in clinical trials. Tumor response is also a guide for the clinician and patient or study. Early, accurate prediction of non-response would allow an early change to second-line treatment, thus sparing patient's unnecessary toxicity, psychological morbidity and delay of initiation of effective treatment. These are very few variables that investigators, as clinicians, can control regarding the management of conjunctival MM. However, early detection, technique and time of surgery may ultimate after tumor recurrence, need for orbital exenteration, tumor metastasis, and patient death. This non-invasive imaging technique that is now available for clinical studies might help in early detecting and preventing above mentioned problems.
- Being tested
- HRT III with Non-Contact Cornea Rostock Module
- Keywords
- Pigmented Lesions, PAM, Ocular lesion
- Medical subject headings
- Nevus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRT III with Non-Contact Cornea Rostock ModuleProcedure or surgery
Confocal imaging of the conjunctival lesion
| Study group | Role | What they receive |
|---|---|---|
| Nevus | Not described Receives: Procedure: HRT III with Non-Contact Cornea Rostock Module | |
| Racial Melanosis | Not described Receives: Procedure: HRT III with Non-Contact Cornea Rostock Module | |
| Primary Acquired Melanosis | Not described Receives: Procedure: HRT III with Non-Contact Cornea Rostock Module | |
| Malignant Melanoma | Not described Receives: Procedure: HRT III with Non-Contact Cornea Rostock Module | |
| Normal | Not described Receives: Procedure: HRT III with Non-Contact Cornea Rostock Module |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pigmented conjunctival lesions
Heidelberg Retina Tomography (HRT) and Optical Coherence Tomography (OCT) will be used to measure pigmented conjunctival lesions. (HRT) is performed with a confocal scanning laser ophthalmoscope. Along with corneal analysis software, the HRT is able to image cells and cell layers within the cornea. Optical Coherence Tomography (OCT) is a noninvasive optical imaging modality analogous to an ultrasound B-scan. OCT images will be used to estimate tumor depth.
Immunohistochemistry results will be recorded from stained tissue samples obtained during surgical resections scheduled for study subjects with newly diagnosed conjunctival lesions. These patients will have HRT and OCT imaging performed prior to their standard of care surgery to remove the conjunctival lesion. Histologic and immunohistochemistry results and clinicopathologic findings will be analyzed by two observers and correlated with IVCM and OCT images of the same lesions.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startSep 2011
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Study was terminated due to low recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NevusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Collaborators
- M.D. Anderson Cancer Center, Wills Eye
- Responsible party
- Sponsor
- Investigators
- Pedram Hamrah, MD, Principal investigator, Massachusetts Eye and Ear InfirmaryCarol Shields, MD, Principal investigator, Wills Eye HospitalArman Mashayekhi, MD, Principal investigator, Wills Eye HospitalBita Esmaeli, MA, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993654
- Sponsor's protocol ID
- 09-04-028
- Status last verified
- Aug 2016
- First submitted
- 19 Oct 2011
- Last updated
- 15 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Study data was not analyzed due to sample size and no statistical power.
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Confocal Microscopy Study of Pigmented Conjunctival Lesions
- ClinicalTrials.gov ID
- NCT01993654
- Acronym / sponsor ID
- 09-04-028
- Keywords
- Pigmented Lesions, PAM, Ocular lesion
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was terminated due to low recruitment.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Collaborators
- M.D. Anderson Cancer Center, Wills Eye
- Study start
- Sep 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 25 Nov 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.
This study aims to validate the use of laser in vivo confocal microscopy as an early diagnostic and differentiation tool of pigmented conjunctival lesions, evaluate the efficacy of in vivo confocal microscopy for follow-up (as a visualizing tool) after tumor resection for early detection of tumor recurrence, and to evaluate the use of in vivo confocal microscopy in evaluation of response to treatment. The modified technique with Heidelberg Retina Tomography (HRT) confocal microscopy and anterior segment optical coherence tomography (OCT) are non-invasive, no-touch, imaging techniques that may help in differentiation of benign lesions like nevi or racial melanosis, from malignant lesions like primary acquired melanosis and malignant melanomas. The OCT will potentially allow to estimate tumor depth in vivo as preliminary studies have shown.
Detailed description
Conjunctival melanoma is a potentially lethal neoplasm, with an average 10-year mortality rate of 30%, and 15-year mortality rate of 45%. This condition occurs mainly in the white population, with rare reports in black and other non-white populations. Recent studies have indicated that like cutaneous melanoma, the incidence of conjunctival melanoma is increasing.
Conjunctival Malignant Melanoma (MM) is also currently diagnosed based upon clinical grounds, through observation of the growth of the suspected lesions over regular intervals of time. Unfortunately simple slit lamp examination is currently the only clinical diagnostic visual instrument available in medical practice, and the early diagnosis of MM by slit-lamp examination is still rather poor. Further the diagnosis of invasive conjunctival MM is currently established by conjunctival excisional biopsy and defined by the invasion of the underlying substantia propria of the conjunctiva by atypical tumor cells, especially when there is loss of the maturation. Regarding the management of malignant melanoma, unfortunately the extensive horizontal and even vertical growth of this neoplasm does not always lend itself to simple excision leading to exenteration. As a vision-sparing alternative, local excision with cryotherapy has become the treatment of choice. Long-term follow-up has shown that local recurrences are common. More recently, topical chemotherapy with mitomycin C (MMC) has been used to treat cases with extensive PAM with atypia , because the pigmented margin is used as a guide for most conservative treatments, the tumor's edge may be missed.
Recurrent conjunctival MM often presents as an amelanotic mass and may be mistaken for pyogenic granuloma in a patient who has had multiple previous excisions of conjunctival MM, even though the original tumor may have been pigmented. Because of the lack of pigment, these tumors can remain unrecognized and progressively enlarge, especially if the patient has had previous surgery and conjunctival scarring. In addition, the tumor margins of recurrent amelanotic conjunctival MM may be indistinct. These factors can lead to delayed recognition and the unnecessary need for exenteration. Despite these radical procedures, which usually lead to loss of vision or the eye, these patients have been shown to have a poor survival rate, suggesting that metastasis has already occurred at the time of treatment. This confirms that the extent of the disease at diagnosis is the most important factor to determine the outcome. Recurrence of conjunctival MM is reported at 26% at 5 years and, 51% at 10 years.
MM of the conjunctival represents one of the greatest challenges in early or preventive detection. Whereas surgical excision in early stages of tumor development is almost always curative, delayed recognition puts the patient at risk of destructive growth and death once the tumor has progressed to competence for metastasis. Accurate diagnosis of pigmented lesions of the conjunctiva such as nevi, primary, and secondary acquired melanosis and MM present a challenge to both the ophthalmologist and the pathologist. It is not possible clinically to distinguish between PAM with and without atypia. The ability to detect early MM remains of paramount importance in our efforts to curtail deaths related to this malignancy. The implementation and utilization of in vivo imaging technologies in clinical practice would enhance our ability to detect MM while this cancer is in its early stages and curable. Further, accurate assessment of therapeutic tumor response is critical for evaluation of chemotherapy results in patients, and in clinical trials. Tumor response is also a guide for the clinician and patient or study. Early, accurate prediction of non-response would allow an early change to second-line treatment, thus sparing patient's unnecessary toxicity, psychological morbidity and delay of initiation of effective treatment. These are very few variables that investigators, as clinicians, can control regarding the management of conjunctival MM. However, early detection, technique and time of surgery may ultimate after tumor recurrence, need for orbital exenteration, tumor metastasis, and patient death. This non-invasive imaging technique that is now available for clinical studies might help in early detecting and preventing above mentioned problems.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Nevus | – | Procedure: HRT III with Non-Contact Cornea Rostock Module |
| Racial Melanosis | – | Procedure: HRT III with Non-Contact Cornea Rostock Module |
| Primary Acquired Melanosis | – | Procedure: HRT III with Non-Contact Cornea Rostock Module |
| Malignant Melanoma | – | Procedure: HRT III with Non-Contact Cornea Rostock Module |
| Normal | – | Procedure: HRT III with Non-Contact Cornea Rostock Module |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female patients over the age of 18 and belonging to one of the following groups will be recruited for this study. Group 1: Nevus Group 2: Racial melanosis Group 3: Primary Acquired Melanosis Group 4: Malignant Melanoma of the Conjunctiva Group 5: Normal Subjects with no pigmented lesions Normal subjects will be recruited from patients normally seen during clinic for cataract evaluations. Groups 1-4 will be identified by the investigators at MEEI and other 2 sites as potential study subjects during regular clinic visits.
Key inclusion criteria (11 listed)
- Age over 18 years
- The ability to provide informed consent for enrollment in the study
- Diagnosis of conjunctival nevus (Group 1 only)
- Diagnosis of racial melanosis (Group 2 only)
- Diagnosis or suspicion of primary acquired melanosis (PAM), scheduled for biopsy (Group 3 only)
Key exclusion criteria (11 listed)
- History of previous ocular surgery within last 3 months
- History of inflammatory eye diseases within last 3 months
- Current or history of glaucoma disease and on glaucoma medication
- Contact lens use within last 3 months
- Physical inability to cooperate for confocal microscopy
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 |
|---|---|---|
| HRT III with Non-Contact Cornea Rostock ModuleConfocal imaging of the conjunctival lesion | Procedure or surgery | Malignant Melanoma, Nevus, Normal, Primary Acquired Melanosis, Racial Melanosis |
Primary outcome
Pigmented conjunctival lesions
Time frame: Day 1
Heidelberg Retina Tomography (HRT) and Optical Coherence Tomography (OCT) will be used to measure pigmented conjunctival lesions. (HRT) is performed with a confocal scanning laser ophthalmoscope. Along with corneal analysis software, the HRT is able to image cells and cell layers within the cornea. Optical Coherence Tomography (OCT) is a noninvasive optical imaging modality analogous to an ultrasound B-scan. OCT images will be used to estimate tumor depth. Immunohistochemistry results will be recorded from stained tissue samples obtained during surgical resections scheduled for study subjects with newly diagnosed conjunctival lesions. These patients will have HRT and OCT imaging performed prior to their standard of care surgery to remove the conjunctival lesion. Histologic and immunohistochemistry results and clinicopathologic findings will be analyzed by two observers and correlated with IVCM and OCT images of the same lesions.
Results and safety
The study was stopped early (reason given: Study was terminated due to low recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2016.
- Individual participant dataSharing planned: No. Study data was not analyzed due to sample size and no statistical power.
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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.
Pedram Hamrah, MD principal investigator
Massachusetts Eye and Ear Infirmary
Carol Shields, MD principal investigator
Wills Eye Hospital
Arman Mashayekhi, MD principal investigator
Wills Eye Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nevus and Racial Melanosis, run by Massachusetts Eye and Ear Infirmary at 3 sites 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 11 inclusion and 11 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: stopped early, as of the sponsor's last update on 15 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
Are results available for this study?
The study was stopped early (reason given: Study was terminated due to low recruitment.). Results are not available in the source record.
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?
Pigmented conjunctival lesions (time frame: Day 1). 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 15 Aug 2016.