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NCT02540135
Fluorescein vs. iMRI in Resection of Malignant High Grade Glioma
NA trial testing fluorescein in High Grade Malignant Neoplasm. Withdrawn.
18 July 2018
Quick facts
| Lead sponsor | University of Colorado, Denver |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | other |
| Start date | 1 March 2015 |
| Primary completion | 18 July 2018 |
| Estimated completion | 18 July 2018 |
| Sites | 1 location across United States |
Drugs / interventions tested
- fluorescein (FLUORESCEIN) — full drug profile →
- intraoperative MRI
Conditions studied
- High Grade Malignant Neoplasm — all drugs for High Grade Malignant Neoplasm →
- Glioblastoma Multiforme — all drugs for Glioblastoma Multiforme →
- Anaplastic Astrocytoma — all drugs for Anaplastic Astrocytoma →
Sponsor
University of Colorado, Denver
Who can join
18 and older, any sex, with High Grade Malignant Neoplasm or Glioblastoma Multiforme. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study plans to learn more about if fluorescein with intraoperative Magnetic Resonance Imaging (MRI) is as good as intraoperative MRI (iMRI) alone in detecting the presence of tumor tissue during surgery. Both fluorescein and intraoperative MRI have been studied and routinely used to aid the neurosurgeon in distinguishing normal brain from tumor, helping the neurosurgeon to safely resect more tumor tissue during surgery. This study will enroll patients with malignant high grade glioma who are going to have a surgery to remove their brain tumor. For half of the patients, fluorescein and intraoperative MRI will be used together during surgery. For half of the patients, only intraoperative MRI will be used during surgery. iMRI is used as final verification of complete, safe resection in both arms.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02540135
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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 NCT02540135 (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 University of Colorado, Denver
- Last refreshed: 20 July 2018
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/NCT02540135.
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