NCT02191488

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
540

participants targeted

Target at P75+ for phase_1

Timeline
8mo left

Started Jul 2014

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jul 2014Dec 2026

Study Start

First participant enrolled

July 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 16, 2014

Completed
11.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

11.5 years

First QC Date

July 9, 2014

Last Update Submit

September 9, 2025

Conditions

Brain Tumors

Keywords

FluorescenceBrain TumorsBrain MetastasesMalignant GliomaBrain Lesions

Outcome Measures

Primary Outcomes (1)

  • Comparison of intraoperative measurements of PpIX concentration to coregistered histopathology

    To estimate the probability of tumor distribution for a given PpIX concentration by comparing intraoperative measurements with coregistered histopathology obtained from biopsy sampling during the procedure

    Up to five years from the first surgery date

Study Arms (1)

Experimental: 5-aminolevulinic acid

EXPERIMENTAL

20mg/kg 3 hours prior to surgery

Drug: 5-aminolevulinic acid

Interventions

5-aminolevulinic acidDRUG
Also known as: 5-ALA
Experimental: 5-aminolevulinic acid

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (1)

  • Roberts DW, Olson JD, Evans LT, Kolste KK, Kanick SC, Fan X, Bravo JJ, Wilson BC, Leblond F, Marois M, Paulsen KD. Red-light excitation of protoporphyrin IX fluorescence for subsurface tumor detection. J Neurosurg. 2018 Jun;128(6):1690-1697. doi: 10.3171/2017.1.JNS162061. Epub 2017 Aug 4.

    PMID: 28777025DERIVED

MeSH Terms

Conditions

Brain NeoplasmsGlioma

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Levulinic AcidsKeto AcidsCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • David W. Roberts, MD

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Surgery (Neurosurgery)

Study Record Dates

First Submitted

July 9, 2014

First Posted

July 16, 2014

Study Start

July 1, 2014

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

September 15, 2025

Record last verified: 2025-09

Locations

US(1)