[68Ga] -SomaKIT-TOC PET / CT in postoperative evaluation of meningioma residues in the cranial base area

Phase 1

• Conditions: evaluation of meningioma residues in the cranial base area; MedDRA version: 21.1Level: PTClassification code 10027191Term: MeningiomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-002205-26-CZ
• Lead Sponsor: Fakultní nemocnice u sv. Anny v Brne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-18
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

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 <1.5x upper limit of normal
7.2. creatinine <1.5x upper limit of normal
7.3. urea <1.5x upper limit of normal
7.4. platelets> 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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified