Lung Cancer in Normal and Malignant TumorsPhase 1NCT01611584
A Proof of Principle Study of Aminolevulinic Acid (ALA) - Induced Fluorescence Detection in Resectable Non-Small Cell Lung Cancer
A Phase 1 study testing ALA-induced Fluorescence in people with Lung Cancer in Normal and Malignant Tumors, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The purpose of this trial is to measure ALA-induced fluorescence in both normal and malignant tissue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer in Normal and Malignant Tumors
- What is being tested?
- ALA-induced Fluorescence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Jul 2014
- 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
- Inclusion Criteria Patients (12 total patients with lung cancer) meeting eligibility criteria will be enrolled.
- Preoperative diagnosis of either presumed or documented non-small cell lung cancer.
- Tumor judged to be suitable for surgical resection based on preoperative evaluation of radiographic studies, pulmonary function tests, performance status and clinical judgment of surgeons at DHMC (Erkmen, Nugent)
- Age ≥ 18 years old.
- Population representative of our usual referral pattern including minority populations, women and those who are financially disadvantaged.
- Subjects capable of giving informed consent
Who cannot join
- Pregnant Women
- Women who are breast feeding
- History of cutaneous photosensitivity
- Porphyria, hypersensitivity to porphyrins, photodermatosis
- Exfoliative dermatitis
- History of liver disease within the last 12 months
Show all 16Show fewer
- Inability to comply with photosensitivity precautions associated with the study
- Inability to give informed consent
- AST, ALT, ALP or bilirubin levels greater than 2.5 times the normal limit at any time during the past 2 months
- Plasma creatinine in excess of 180 umol/L
- Women who are breast feeding
- History of cutaneous photosensitivity
- Porphyria, hypersensitivity to porphyrins, photodermatosis
- Exfoliative dermatitis
- History of liver disease within the last 12 months
- Inability to comply with photosensitivity precautions associated with the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
The purpose of this trial is to measure ALA-induced fluorescence in both normal and malignant tissue.
- Being tested
- ALA-induced Fluorescence
- Keywords
- ALA, Florescence, Lung cancer
- Medical subject headings
- Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALA-induced FluorescenceDrug
ALA Dose- 20 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| ALA | Experimental | No arms for the trial. Participants will have proven or presumed lung cancer and will be assessed for participant by a research team member. Receives: Drug: ALA-induced Fluorescence |
What is being measured
The primary outcome is the main question the study is designed to answer.
ALA-induced fluorescence- lung cancer
Determine the relationship between ALA induced protoporphyrin IX (PplX) flourescence and histology in both normal and malignant tumors.
Measured: Participants will be followed for duration of the hospital stay, and up to 3 weeks after
Secondary outcomes (1)
Determine Feasibility of fluorescence
Determine feasibility of integrating fluorescence detection into surgical pratice of resection for lung cancer.
Measured: Participants will be followed for the duration of their hospital study and up to 3 weeks after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study startJun 2010
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer in Normal and Malignant TumorsStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cherie P Erkmen, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611584
- Sponsor's protocol ID
- D1046
- Status last verified
- Nov 2014
- First submitted
- 10 Apr 2012
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Principle Study of Aminolevulinic Acid (ALA) - Induced Fluorescence Detection in Resectable Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01611584
- Acronym / sponsor ID
- D1046
- Keywords
- ALA, Florescence, Lung cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 5 Jun 2012 (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 purpose of this trial is to measure ALA-induced fluorescence in both normal and malignant tissue.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALA | Experimental | Drug: ALA-induced FluorescenceNo arms for the trial. Participants will have proven or presumed lung cancer and will be assessed for participant by a research team member. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Inclusion Criteria Patients (12 total patients with lung cancer) meeting eligibility criteria will be enrolled.
- Preoperative diagnosis of either presumed or documented non-small cell lung cancer.
- Tumor judged to be suitable for surgical resection based on preoperative evaluation of radiographic studies, pulmonary function tests, performance status and clinical judgment of surgeons at DHMC (Erkmen, Nugent)
- Age ≥ 18 years old.
- Population representative of our usual referral pattern including minority populations, women and those who are financially disadvantaged.
Key exclusion criteria (16 listed)
- Pregnant Women
- Women who are breast feeding
- History of cutaneous photosensitivity
- Porphyria, hypersensitivity to porphyrins, photodermatosis
- Exfoliative dermatitis
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 |
|---|---|---|
| ALA-induced FluorescenceALA Dose- 20 mg/kg | Drug | ALA |
Primary outcome
ALA-induced fluorescence- lung cancer
Time frame: Participants will be followed for duration of the hospital stay, and up to 3 weeks after
Determine the relationship between ALA induced protoporphyrin IX (PplX) flourescence and histology in both normal and malignant tumors.
1 secondary outcome
Determine Feasibility of fluorescence
Time frame: Participants will be followed for the duration of their hospital study and up to 3 weeks after
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 13 Nov 2014.
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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.
Cherie P Erkmen, MD principal investigator
Dartmouth-Hitchcock Medical Center
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 ALA-induced Fluorescence in people with Lung Cancer in Normal and Malignant Tumors, run by Dartmouth-Hitchcock Medical Center 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 6 inclusion and 16 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 13 Nov 2014. 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?
ALA-induced fluorescence- lung cancer (time frame: Participants will be followed for duration of the hospital stay, and up to 3 weeks after). 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 13 Nov 2014; AzTrials last refreshed its copy on 8 Nov 2026.