ALA-induced PpIX Fluorescence During Brain Tumor Resection

Study Purpose

Removing a tumor from a patients brain is hard to do because, very often, brain tumors do not have boundaries that are easy for the patients surgeon to find. In many cases, the surgeon can't tell exactly where the tumor begins or ends. The surgeon usually can remove most of the patient's tumor by looking at the MRI images that were taken of the patient's brain before surgery. However, the surgeon does not have any good way to tell if the entire tumor has been removed or not. Removing the entire tumor is very important because leaving tumor behind may allow it to grow back which could decrease the chances of survival.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 21 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Preoperative diagnosis of either presumed first-time low or high grade glioma, or recurrent glioma, or metastasis, or meningioma - Tumor judged to be suitable for open cranial resection based on preoperative imaging studies.
  • - Patient or LAR able to provide written informed consent.
  • - No serious associated psychiatric illnesses.
  • - Age > 21 years old.

Exclusion Criteria:

  • - Pregnant women or 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.
  • - Elevated liver function levels greater than 2.5 times the normal limit from laboratory tests conducted within 30 days prior to surgery.
  • - Inability to comply with the photosensitivity precautions associated with the study.
- Plasma creatinine in excess of 180umol/L within 30 days prior to surgery

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02191488
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

David W. Roberts
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

David W. Roberts, MD
Principal Investigator Affiliation Dartmouth-Hitchcock Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain Tumors
Arms & Interventions

Arms

Experimental: Experimental: 5-aminolevulinic acid

20mg/kg 3 hours prior to surgery

Interventions

Drug: - 5-aminolevulinic acid

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire

Status

Recruiting

Address

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756

Site Contact

Margaret A Notestine, CCRC

Margaret.A.Notestine@hitchcock.org

603-650-4607

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