Using FET-PET fused with MRI to better map and treat glioblastoma
Application of FET-PET in Fusion With MRI in the Surgical Treatment and Postoperative Radiotherapy of Glioblastoma Multiforme - a Randomized, Blinded, Prospective Study
This will try using FET-PET combined with contrast MRI to better identify tumor tissue and guide surgery and treatment for adults with a single, newly diagnosed glioblastoma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 189 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Copernicus Memorial Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Lodz, Łódź Voivodeship) |
| Trial ID | NCT06466031 on ClinicalTrials.gov |
What this trial studies
At Copernicus Memorial Hospital, eligible adults with a single, contrast-enhancing glioblastoma will receive preoperative FET-PET scans and standard contrast-enhanced MRI that are fused to create a combined metabolic and anatomical map. The fused images will be used to inform the planned craniotomy and extent of tumor resection and to guide subsequent treatment planning. The protocol enrolls primary (nonrecurrent) tumors, patients aged 18–69 with KPS ≥70, and excludes multifocal disease or prior oncologic treatment. Study outcomes will focus on imaging-defined resection extent and early patterns of local recurrence.
Who should consider this trial
Good fit: Ideal candidates are adults 18–69 with a single, newly diagnosed contrast-enhancing glioblastoma who are eligible for craniotomy, have KPS ≥70, no other active cancers, and no contraindications to contrast agents or surgery.
Not a fit: Patients with multifocal or recurrent glioblastoma, prior neurosurgery/radiation/chemotherapy for the tumor, poor functional status, or medical contraindications to surgery or contrast agents are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could more accurately show tumor beyond the contrast-enhancing margin and help achieve more complete or better-targeted resections and postoperative planning.
How similar studies have performed: FET-PET fused with MRI has been used in other centers and shown improved tumor delineation and surgical planning, although a clear survival benefit has not been definitively proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Single macroscopic tumor focus with the appearance of glioblastoma multiforme on MRI with contrast - contrast-enhancing lesion, completely or with central necrosis, with surrounding edema. * No history of cancer in other organs. No suspicious lesions on X-ray of the chest and abdomen (CT with contrast). * No clinical suspicion of brain abscess - no meningeal symptoms, signs of neuroinfection, fever, elevated inflammatory parameters. * Primary tumor, without neurosurgical, radiotherapy or oncology intervention. Prior tumor biopsy is allowed. * Tumor eligible for surgical treatment - craniotomy and tumor resection. * Age ≥ 18 years but \< 70 years old. * Quality of life assessment: KPS ≥ 70. * Informed patient consent to the study and proposed treatment. * No allergy to contrast agents used in PET and MRI. * No medical contraindications to neurosurgery - craniotomy and resection. Exclusion Criteria: * Multifocal brain tumor. * Recurrence of glioblastoma multiforme. * Clinical or radiological suspicion of brain metastasis or brain abscess. * Postoperative histopathological diagnosis other than WHO grade IV glioblastoma. * Medical contraindications to any surgery under general anesthesia. * Pregnancy, breastfeeding. * Known allergy to gadolinium contrast or radiopharmaceutical tracing agent.
Where this trial is running
Lodz, Łódź Voivodeship
- Copernicus Memorial Hospital in Łódź, Poland — Lodz, Łódź Voivodeship, Poland (Recruiting)
Study contacts
- Principal investigator: Kamil Krystkiewicz, PhD — Department of Neurosurgery and Neurooncology, Copernicus Memorial Hospital in Łódź, Poland
- Study coordinator: Kamil Krystkiewicz, PhD
- Email: kamil.krystkiewicz@gmail.com
- Phone: +48426895341
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.