MelanomafPAMNCT00776945
Feasibility and Functionality of fPAM Imaging in Melanoma
An observational study of Melanoma, run by Washington University School of Medicine at 2 sites in United States.
Trial summary
Melanoma is a cutaneous malignancy that has the potential for local (skin) and regional (lymph node) recurrence. These recurrences may be difficult to detect in their earliest stages. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2009to Dec 2014
- 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: Patients with Stage I - III melanoma.
Who may be able to join
- Adult patients (> 18 yrs of age) with recently diagnosed or a history of, Stage I - III melanoma who are able to give informed consent.
Who cannot join
- Patients with melanomas < 1mm.
- Pregnant females.
- Children and young adults < 18 yrs of age and patients who are unable to give informed consent.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Washington University School of Medicine
St Louis, Missouri, 63110
Washington University
St Louis, Missouri, 63110
About this study
Official title: Determine the Feasibility and Functionality of fPAM Imaging for the in Vivo Characterization and Early Diagnosis of Melanoma
Melanoma is a cutaneous malignancy that has the potential for local (skin) and regional (lymph node) recurrence. These recurrences may be difficult to detect in their earliest stages. We are attempting to use novel form of skin imaging that uses ultrasound combined with laser to identify these recurrences early, when they may be most amenable to treatment. This imaging will detect melanoma pigment below the surface of the skin and in the draining lymph nodes, as well as new blood vessel formation that occurs with these loco-regional metastases.
Read the detailed description
recruiting healthy individuals with pigmented lesions and individuals with melanoma and pigmented lesions
- Conditions
- Melanoma
- Medical subject headings
- Melanoma
What is being measured
The primary outcome is the main question the study is designed to answer.
fPAM is a hybrid imaging technique that detects absorbed diffuse photons ultrasonically through the photoacoustic (PA) effect
Evaluate pigmented lesions for depth, width, total hemoglobin saturation, melanin distribution, and melanin concentration using fPAM in vivo and ex vivo
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2008 (estimated)
- Study startJan 2009
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: no funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Washington University School of 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lynn Cornelius, MD, Washington University School of Medicine
- Investigators
- Lynn A Cornelius, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00776945
- Sponsor's protocol ID
- 07-0635
- Acronym
- fPAM
- Status last verified
- Nov 2013
- First submitted
- 20 Oct 2008
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determine the Feasibility and Functionality of fPAM Imaging for the in Vivo Characterization and Early Diagnosis of Melanoma
- ClinicalTrials.gov ID
- NCT00776945
- Acronym / sponsor ID
- fPAM / 07-0635
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: no funding
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 22 Oct 2008 (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.
Melanoma is a cutaneous malignancy that has the potential for local (skin) and regional (lymph node) recurrence. These recurrences may be difficult to detect in their earliest stages. We are attempting to use novel form of skin imaging that uses ultrasound combined with laser to identify these recurrences early, when they may be most amenable to treatment. This imaging will detect melanoma pigment below the surface of the skin and in the draining lymph nodes, as well as new blood vessel formation that occurs with these loco-regional metastases.
Detailed description
recruiting healthy individuals with pigmented lesions and individuals with melanoma and pigmented lesions
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Stage I - III melanoma.
Key inclusion criteria (1 listed)
- Adult patients (> 18 yrs of age) with recently diagnosed or a history of, Stage I - III melanoma who are able to give informed consent.
Key exclusion criteria (3 listed)
- Patients with melanomas < 1mm.
- Pregnant females.
- Children and young adults < 18 yrs of age and patients who are unable to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
fPAM is a hybrid imaging technique that detects absorbed diffuse photons ultrasonically through the photoacoustic (PA) effect
Time frame: baseline
Evaluate pigmented lesions for depth, width, total hemoglobin saturation, melanin distribution, and melanin concentration using fPAM in vivo and ex vivo
Results and safety
The study was stopped early (reason given: no funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
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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.
Lynn A Cornelius, MD principal investigator
Washington University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by Washington University School of Medicine at 2 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 1 inclusion and 3 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 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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: no funding). 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?
fPAM is a hybrid imaging technique that detects absorbed diffuse photons ultrasonically through the photoacoustic (PA) effect (time frame: baseline). 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 8 Jun 2015.