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NCT07438860
Fluorescence-Guided Imaging of Brain Tumors: A Safety Study Using SBK2-ICG
Phase 1 trial testing SBK2-ICG in Malignant Brain Tumors in 12 participants. Not yet recruiting.
1 November 2026
Quick facts
| Lead sponsor | Tiffany Hodges |
|---|---|
| Phase | Phase 1 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 12 |
| Start date | 2 March 2026 |
| Primary completion | 1 November 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- SBK2-ICG — full drug profile →
- Craniotomy (Standard of Care)
Conditions studied
- Malignant Brain Tumors — all drugs for Malignant Brain Tumors →
- Glioma — all drugs for Glioma →
Sponsor
Tiffany Hodges — full company profile →
Who can join
18 and older, any sex, with Malignant Brain Tumors or Glioma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Participants in this research study are people who are likely to have, or have been diagnosed with a brain tumor, for which surgical removal (or "resection") is the standard of care treatment. The purpose of this study is to see whether a drug called SBK2-ICG can be used to locate the true outline or "edges" of the tumor. If the tumor outline could be accurately identified at the time of surgery, the fullest extent of tumor could be removed while sparing the normal brain tissue. Participants will receive SBK2-ICG about an hour before they receive surgery. The extent of surgery to be performed will not be changed in this study. Researchers will only use the information from the study to determine the best SBK2-ICG dose for accurate tumor margin (i.e., the border or edges of the tumor with the normal brain) detection so that no tumor is left behind. The use of SBK2-ICG in brain tumors is experimental, which means that the U.S. Food and Drug Administration (FDA) has not approved it for use to locate brain tumors. However, the use of the drug SBK2-ICG for the purposes of this study is on file with the FDA.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07438860
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other recruiting trials for Malignant Brain Tumors
Currently open trials in the same condition.
- NCT07158710 — Phase I Study of HSK42360 in Malignant Brain Tumors With BRAF V600 Mutation · Phase 1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07438860 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tiffany Hodges
- Last refreshed: 27 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07438860.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing