Diagnostic value of 64CuCl2 in high grade glioma

Phase 1

• Conditions: pediatric patients with HGG/DIPG; 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: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2018-004667-30-IT
• Lead Sponsor: ENTE OSPEDALIERO OSPEDALI GALLIERA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-16
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Histologically or radiologically confirmed High grade Glioma or diffuse intrinsic pontine glioma (DIPG)

2. Measurable disease (at least one objectively bi-dimensionally measurable lesion (> 1 cm in its largest
dimension by RM scan) as demonstrated by RM scan.

3.KPS = 60.

4. A life expectancy > 3 months.

5. Male or female aged ranging from 5 to 18 years.
6. Normal marrow function defined as:
a. Absolute neutrophil count = 1.5 x 109/l
b. Platelet count = 150 x 109/l
c. Haemoglobin = 9 g/dl.
7. Adequate hepatic function, defined as:
a. AST/ALT = 2.5 x upper limit of normal (ULN) (or = 5.0 x ULN if liver involvement by primary disease) direct bilirubin = 1.5 ULN
b. Normal ALP values
c. Normal coagulation parameters.
8. Adequate renal function as demonstrated by a serum creatinine = 1.5 mg/dl or a creatinine clearance > 60 ml/min.
9. Negative human chorionic gonadotropin (hCG) test in women of childbearing potential. Sexually active male and female patients of childbearing potential must agree to use an effective method of birth control (e.g. barrier methods with spermicides, oral or parenteral contraceptives and/or intrauterine devices) during the entire duration of the study and for 4 months after final administration of 64CuCl2, or the patient must be sterile (with documentation in the patient’s medical records).
Note: Sterility (in female patients) must be confirmed in the patients’ medical records and can be defined as any of the following: surgical hysterectomy with bilateral oophorectomy; radiation-induced oophorectomy with last menses >1 year ago; chemotherapy-induced menopause with 1 year interval since last menses.
10. Written, informed consent prior to the present study and to any study-specific screening procedures, with the understanding that the consent may be withdrawn by the patient or by the parents/legal tutors at any time without prejudice.
11. Capable of understanding the protocol requirements, is willing and able to comply with the study protocol procedures, and has signed the informed consent document.

15.TBR > 5
Are the trial subjects under 18? yes
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 2
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Histology other than High Grade Glioma.
2. Contraindication to MRI with gadolinium.
3. Copper metabolic disorders (i.e. known Wilson disease or Menkes disease).
4. Patients who have not recovered from adverse events Grade > 1 due to diagnostic injection of Cuprymina.
5. Pregnant or breastfeeding women.
6.Sexually active male and female patients of childbearing potential without use of an effective method of birth control.
7.Known HIV disease or acquired immunodeficiency syndrome-related illness or active hepatitis B or C infection.
8. Uncontrolled Diabetes

Study & Design

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