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Abstract Details

Validating Advanced Volumetric Techniques for Cutaneous Neurofibromas in Clinical Trials
Neuro-oncology
S14 - Translational and Clinical Advances in Neuro-oncology (2:28 PM-2:39 PM)
009

cNF affect up to 99% of patients with neurofibromatosis 1 (NF1) and are a major source of social/emotional distress. Treatment options for cNF are limited and drug development has been hampered by the inability to accurately detect small changes in tumor size. Calipers, the current standard for cNF measurement, can only assess a subset of cNF that are above the skin surface, cannot assess deep portions of tumor, and are subject to inter-rater variability. A reliable measurement technique for cNF is a critical gap for development of therapies for these tumors.

To assess the ability of digital calipers, 3D camera,and high frequency ultrasound (HFUS) to measure cutaneous neurofibromas (cNF) in patients with NF1.

We are recruiting participants with NF1 to a study assessing the intra-and inter-rater reliability of various measurement techniques for cNF. Six cNF on each NF1 participant were assessed independently by three different examiners using calipers, 3D photography, and HFUS.  Photographs and ultrasound images were processed using manufacturer provided software, and tumors were measured via manual outlining of tumors by up to three assessors. Linear and volumetric assessments were compared using intraclass correlation coefficient (ICC) to determine the intra-and inter-rater reliability of each measurement technique. 

Five patients have participated to date. Reproducibility of image acquisition and measurement was excellent within and across examiners (ICC > 0.90 for HFUS and 3D camera techniques).  Acquisition of images was rapid (less than 30 seconds) and examiners found these devices easy to use. Both systems require no action from the patient and are easily tolerated. 

HFUS and 3D photography are feasible, reliable,non-invasive methods for measurement of cNF. These methods are currently being evaluated as potential methods to assess changes in cNF size over time. This information will ultimately inform clinical trial design and facilitate the development of interventional treatments for cNF.

 

Authors/Disclosures
Raquel D. Thalheimer
PRESENTER
Raquel D. Thalheimer has received personal compensation for serving as an employee of Jhpeigo.
Vanessa Merker (Massachusetts General Hospital) The institution of Vanessa Merker has received research support from Children's Tumor Foundation . The institution of Vanessa Merker has received research support from NF Northeast. The institution of Vanessa Merker has received research support from Patient Centered Outcomes Research Institute. The institution of Vanessa Merker has received research support from U.S. Department of Defense . The institution of Vanessa Merker has received research support from Neurofibromatosis Therapeutic Accleration Project. Vanessa Merker has received personal compensation in the range of $10,000-$49,999 for serving as a Science Writer with Neurofibromatosis Network.
Ina Ly, MD (Pappas Center for Neuro-Oncology) An immediate family member of Dr. Ly has received personal compensation for serving as an employee of Enanta Pharmaceuticals. Dr. Ly has received research support from Department of Defense. An immediate family member of Dr. Ly has received intellectual property interests from a discovery or technology relating to health care.
No disclosure on file
No disclosure on file
No disclosure on file
No disclosure on file
Justin T. Jordan, MD, MPH, FAAN (Massachusetts General Hospital) Dr. Jordan has received personal compensation for serving as an employee of City of Beverly. An immediate family member of Dr. Jordan has received personal compensation for serving as an employee of Dietitians on Demand. An immediate family member of Dr. Jordan has received personal compensation for serving as an employee of Genesis HR Solutions. Dr. Jordan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Navio Theragnostics. Dr. Jordan has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Recursion Pharmaceuticals, Inc. Dr. Jordan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Shepherd Therapeutics. Dr. Jordan has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion Pharmaceuticals. Dr. Jordan has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Akeila Bio. Dr. Jordan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Springworks Therapeutics. Dr. Jordan has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck Pharmaceuticals. Dr. Jordan has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Continental Casualty Company. Dr. Jordan has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for HennLesperance. Dr. Jordan has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Rhoades McKee. Dr. Jordan has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Wheeler Trigg O'Donnell. Dr. Jordan has stock in Navio Theragnostics. Dr. Jordan has stock in The Doctor Lounge. An immediate family member of Dr. Jordan has stock in OldGate. Dr. Jordan has stock in Akeila Bio. Dr. Jordan has stock in Shepherd Therapeutics. Dr. Jordan has stock in Khora TX. The institution of Dr. Jordan has received research support from NIH. The institution of Dr. Jordan has received research support from Department of Defense. The institution of Dr. Jordan has received research support from PCORI. Dr. Jordan has received publishing royalties from a publication relating to health care. Dr. Jordan has a non-compensated relationship as a board member with United Council for Neurologic Subspecialties that is relevant to AAN interests or activities.
Alona Muzikansky No disclosure on file
No disclosure on file
Jaishri Blakeley, MD, FAAN (Johns Hopkins University School of Medicine) Dr. Blakeley has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Springworks Therapeutics.
No disclosure on file
Scott R. Plotkin, MD, PhD, FAAN (Mass General Cancer Center) Dr. Plotkin has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for NFlection Therapeutics. Dr. Plotkin has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Akouos. Dr. Plotkin has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for SonALAsense. Dr. Plotkin has stock in NFlection Therapeutics. Dr. Plotkin has stock in NF2 Therapeutics. Dr. Plotkin has stock in SonALAsense. Dr. Plotkin has received research support from Children's Tumor Foundation. Dr. Plotkin has received research support from Department of Defense. Dr. Plotkin has received research support from National Institutes of Health. Dr. Plotkin has received intellectual property interests from a discovery or technology relating to health care.