NCT03407781

IRDye800CW-BBN PET-NIRF Imaging Guiding Surgery in Patients With Lower Grade Glioma

Completed Phase 1 Last updated 6 August 2024

What this trial tests

Phase 1 trial testing 68Ga-BBN-IRDye800CW in Glioma in 52 participants. Completed in 17 August 2018.

Timeline

1 January 2016

Primary endpoint
17 August 2018

17 August 2018

Quick facts

Lead sponsor	Deling Li
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	52
Start date	1 January 2016
Primary completion	17 August 2018
Estimated completion	17 August 2018
Sites	1 location across China

Drugs / interventions tested

• 68Ga-BBN-IRDye800CW — full drug profile →

Conditions studied

• Glioma — all drugs for Glioma →

Sponsor

Deling Li

Who can join

Adults 18 to 70, any sex, with Glioma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open-label positron emission tomography/near infrared (PET/NIRF) study to investigate the imaging navigation performance and evaluation efficacy of dual modality imaging probe 68Ga-BBN-IRDye800CW in patients with lower grade glioma. A single dose of 40μg/111-148 Mega-Becquerel (MBq) 68Ga-NOTA-BBN and 1.0- or 2.0- mg/ml IRDye800CW-BBN will be injected intravenously before the operation and intraoperative respectively. Visual and semiquantitative method will be used to assess the PET images and real-time margins localization for surgical navigation.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting MMP-14 for dual PET and fluorescence imaging of glioma in preclinical models.
   Kasten BB, Jiang K, Cole D, Jani A, et al · · 2020 · cited 43× · PMID 31773232 · DOI 10.1007/s00259-019-04607-x
2. Fluorescence-Guided Surgery in the Surgical Treatment of Gliomas: Past, Present and Future.
   Sun R, Cuthbert H, Watts C. · · 2021 · cited 28× · PMID 34298721 · DOI 10.3390/cancers13143508
3. Lower-grade gliomas surgery guided by GRPR-targeting PET/NIR dual-modality image probe: a prospective and single-arm clinical trial.
   Chen L, Zhang J, Chi C, Che W, et al · · 2024 · cited 17× · PMID 38169486 · DOI 10.7150/thno.91554
4. Refining Glioblastoma Surgery through the Use of Intra-Operative Fluorescence Imaging Agents.
   Netufo O, Connor K, Shiels LP, Sweeney KJ, et al · · 2022 · cited 14× · PMID 35631376 · DOI 10.3390/ph15050550
5. Dual-Labeled Small Peptides in Cancer Imaging and Fluorescence-Guided Surgery: Progress and Future Perspectives.
   Minges P, Eder M, Eder AC. · · 2025 · cited 6× · PMID 40005958 · DOI 10.3390/ph18020143
6. Identifying Molecular Probes for Fluorescence-Guided Surgery in Neuroblastoma: A Systematic Review.
   Hennessy M, Neville JJ, Privitera L, Sedgwick A, et al · · 2025 · PMID 40426729 · DOI 10.3390/children12050550