evaluation of meningioma residues in the cranial base area MedDRA version: 21.1 Level: PT Classification code 10027191 Term: Meningioma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Galliapharm
Pharmaceutical Form: Radionuclide generator
INN or Proposed INN: GALLII (68GA) CHLORIDUM
Other descriptive name: GALLIUM (68GA)
Concentration unit: GBq gigabecquerel(s)
Concent
Sponsors
Fakultní nemocnice u sv. Anny v Brne
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. age =18 years 2. histologically proven diagnosis of WHO grade I-III meningioma in the area of ??the base of the skull 3. condition after cranial meningioma surgery in the previous 20 years 4. stage of Simpson II - V resection (ie patients with Simpson I resection will not be included, in whom the complete tumor has been clearly removed, including the surrounding dura mater and bone to a sufficient extent) 5. signed informed consent 6. ECOG PS 0-2 7. laboratory values: 7.1. bilirubin 50x 10 to 9 / l 8. ability to undergo MR and PET / CT examinations 9. the ability of the assessment body to cooperate as required by the Protocol 10. participants in a clinical trial of childbearing potential must agree to the use of prescribed methods of contraception for at least one month following a single dose of study medication women - observance of sexual abstinence or use of an adequate contraceptive method (ie condom) in the case of sexual intercourse, ev. the presence of bilateral tubal occlusion or vasectomy in the partner men - observance of sexual abstinence or use of an adequate contraceptive method (ie condom) in case of sexual intercourse Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. known hypersensitivity to any component of the investigational product according to SPC 2. history of severe forms of polyvalent allergy 3. inability to undergo MR examination (neurostimulator, pacemaker, cochlear implant, metal implant of unclear anamnesis, metal chips in the eye) 4. morbid obesity or deformity of the torso preventing passage through the opening of the CT or MR device 5. claustrophobia or inability to lie down for 20 minutes without moving 6. the presence of any mental, family, social or geographical facts that could impede the procedure in accordance with the protocol - these facts must be discussed with the subject before inclusion in the clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evidence and evaluation of radiopharmaceutical accumulation [68Ga] -SomaKIT-TOC in patients after extinction of meningioma in the cranial base area;Secondary Objective: Volumetric comparison of [68Ga] -SomaKIT-TOC PET / CT positivity and saturation after administration of a contrast agent to MR in the area of the original tumor. We verify the assumption that [68Ga] -SomaKIT-TOC can be used to refine the extent of meningioma residue for possible postoperative radiotherapy or prospective monitoring of its extent. Comparison of the sensitivity of [68Ga] -SomaKIT-TOC PET / CT and MR with a contrast agent in distinguishing residual meningioma tumor tissue from postoperative changes in the cranial base. Safety assessment of the applied product [68Ga] -SomaKIT-TOC.;Primary end point(s): Visual identification of pathological (tumor) tissue using semi-quantitative evaluation of the ratio (T / B) of radiopharmaceutical accumulation in the lesion (SUVmaxTumor) to background (SUVmaxBackground)> 1.3; RT / B = SUVmaxT / SUVmaxB.;Timepoint(s) of evaluation of this end point: Day 0 (day of examination) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Volumetric comparison of positive areas according to [68Ga] -SomaKIT-TOC PET / CT (area with radiopharmaceutical accumulation T / B higher than 1.3 and MR (saturation area after contrast administration). We compare the correlation between tumor-positive regions according to [68Ga] -SomaKIT-TOC PET / CT T / B above 1.3 using the cranial base segmentation method and tumor-positive regions according to MR with a contrast agent based on the evaluation of an independent radiologist.;Timepoint(s) of evaluation of this end point: Day 0 (day of examination) | — |
Countries
Czech Republic
Contacts
Public ContactOddelení klinických studií
Fakultní nemocnice u sv. Anny v Brne
Outcome results
None listed