Evidence map›Paper›PMID 33954826›Full record

ArticleEuropean journal of nuclear medicine and molecular imaging2021

A phase I study of a PARP1-targeted topical fluorophore for the detection of oral cancer.

Paula Demétrio de Souza França, Susanne Kossatz, Christian Brand, Daniella Karassawa Zanoni, Sheryl Roberts, Navjot Guru, Dauren Adilbay, Audrey Mauguen, Cristina Valero Mayor, Wolfgang A Weber and 5 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in European journal of nuclear medicine and molecular imaging, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03085147 (A Phase I/II Study of the Fluorescent PARP1 Binding Imaging Agent PARPi-FL in Patients With Oral Squamous Cell Carcinomas), which is not on this map. Cited by 30 papers.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed
5.0field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03085147 phase1 / phase2active not recruitingnot on this map

A Phase I/II Study of the Fluorescent PARP1 Binding Imaging Agent PARPi-FL in Patients With Oral Squamous Cell Carcinomas

TypeinterventionalSponsorMemorial Sloan Kettering Cancer CenterRan2017 to 2027Enrolled23ConditionsOral Squamous Cell Carcinoma (OSCC)ArmsOlaparib
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 63 citations in OpenAlex.

  1. Targeted Fluorescence Imaging of Bevacizumab-800CW in Patients with Neovascular Age-Related Macular Degeneration.Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2026
    Trial
  2. Trial
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  6. Review
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  8. Article
  9. Review
  10. Article
  11. Article
  12. Translational Potential of Fluorescent PARP1 Inhibitor as a Molecular Contrast Agent for Diagnosis of Basal Cell Carcinoma.Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2025
    Article
  13. Review
  14. The Use of Fluorescent Markers to Detect and Delineate Head and Neck Cancer: A Scoping Review.Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery · 2025
    Article
  15. Review
  16. Article
  17. Review
  18. A Prospective Double-Blinded Comparison of Reflectance Confocal Microscopy with Conventional Histopathology for In Vivo Assessment in Oral Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
    Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 2 institutions in 3 countries.

Paula Demétrio de Souza França *Department of Radiology, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA.
Susanne Kossatz *Department of Radiology, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA.
Christian BrandDepartment of Radiology, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA.
Daniella Karassawa ZanoniDepartment of Radiology, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA.
Sheryl RobertsDepartment of Radiology, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA.
Navjot GuruDepartment of Radiology, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA.
Dauren AdilbayDepartment of Radiology, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA.
Audrey MauguenDepartment of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Cristina Valero MayorDepartment of Surgery, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA.
Wolfgang A WeberDepartment of Radiology, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA.
Heiko SchöderDepartment of Radiology, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA.
Ronald A GhosseinDepartment of Pathology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Ian GanlyDepartment of Surgery, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA.
Snehal G PatelDepartment of Surgery, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA. patels@mskcc.org.
Thomas ReinerDepartment of Radiology, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA. reinert@mskcc.org.ORCID 0000-0002-7819-5480
Memorial Sloan Kettering Cancer Center · USUniversity of Iowa · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
Radioiodinated Multifunctional PARP1 Imaging Probes for Diagnosis and TherapyR01CA204441 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI PILLARSETTY, NAGAVARAKISHORE · 2016 to 2020
$2.9M
Rapid, quantitative and affordable point-of-care diagnostics for oral and oropharyngeal cancerR43CA228815 · NCI · SUMMIT BIOMEDICAL IMAGING, LLC · PI BRAND, CHRISTIAN, REINER, THOMAS · 2018 to 2018
$300k
NCI NIH HHS P30 CA008748NCI NIH HHS R01 CA204441NCI NIH HHS R43 CA228815
6 · The paper itself

Abstract

backgroundVisual inspection and biopsy is the current standard of care for oral cancer diagnosis, but is subject to misinterpretation and consequently to misdiagnosis. Topically applied PARPi-FL is a molecularly specific, fluorescent contrast-based approach that may fulfill the unmet need for a simple, in vivo, non-invasive, cost-effective, point-of-care method for the early diagnosis of oral cancer. Here, we present results from a phase I safety and feasibility study on fluorescent, topically applied PARPi-FL. Twelve patients with a histologically proven oral squamous cell carcinoma (OSCC) gargled a PARPi-FL solution for 60 s (15 mL, 100 nM, 250 nM, 500 nM, or 1000 nM), followed by gargling a clearing solution for 60 s. Fluorescence measurements of the lesion and surrounding oral mucosa were taken before PARPi-FL application, after PARPi-FL application, and after clearing. Blood pressure, oxygen levels, clinical chemistry, and CBC were obtained before and after tracer administration.

resultsPARPi-FL was well-tolerated by all patients without any safety concerns. When analyzing the fluorescence signal, all malignant lesions showed a significant differential in contrast after administration of PARPi-FL, with the highest increase occurring at the highest dose level (1000 nM), where all patients had a tumor-to-margin fluorescence signal ratio of >3. A clearing step was essential to increase signal specificity, as it clears unbound PARPi-FL trapped in normal anatomical structures. PARPi-FL tumor cell specificity was confirmed by ex vivo tabletop confocal microscopy. We have demonstrated that the fluorescence signal arose from the nuclei of tumor cells, endorsing our macroscopic findings.

conclusionsA PARPi-FL swish & spit solution is a rapid and non-invasive diagnostic tool that preferentially localizes fluorescent contrast to OSCC. This technique holds promise for the early detection of OSCC based on in vivo optical evaluation and targeted biopsy of suspicious lesions in the oral cavity.

trial registrationClinicaltrials.gov -NCT03085147, registered on March 21st, 2017.

Indexed as

Carcinoma, Squamous CellMouth NeoplasmsFluorescent DyesHumansPoly (ADP-Ribose) Polymerase-1Fluorescent DyesPARP1 protein, humanPoly (ADP-Ribose) Polymerase-1Fluorescence-guided-detectionMolecular imagingOral cancerPARP1PARPi-FLSwishTopical application

Identifiers

PMID33954826
PMCPMC9447371
OpenAlexW3157310919

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.