68Ga/177Lu-PSMA Theranostics in Recurrent Grade 3 and Grade 4 Glioma

Summary

This interventional, clinical pilot-study will initiate and evaluate 68Ga/177Lu-PSMA theranostics in Norway as treatment alternative for patients with recurrent grade 3 and grade 4 gliomas. The main goal is to improve existing diagnostic and therapeutic methods in glioma management, and introduce a novel, well-tolerated radionuclide treatment that possibly can increase the overall survival and quality of life for a patient group that today have very short expected survival and no standard recommended therapy.

Eligibility

Inclusion Criteria:

* A previous diagnosis of histologically confirmed WHO grade 3 or grade 4 glioma
* Radiologically (MRI) confirmed tumor relapse/progression ≥ 12 weeks since completed radiotherapy or suspicion of recurrence where inclusion in the theranostic part of study could be indicated
* Must be ≥ 18 years old
* Written informed consent for study participation
* Negative pregnancy test no longer than 14 days prior to enrollment
* Life expectancy \> 12 weeks
* Karnofsky performance status ≥ 70% (must be able to care for self after radionuclide therapy)
* High tumor uptake on diagnostic imaging with 68Ga -PSMA.
* Tumor not amendable for radiotherapy or surgery, and treating oncologist think that there are no other preferable systemic therapy options (e.g temozolomide, PCV or lomustine monotherapy).
* Women of childbearing potential (WOCBP) defined as fertile, following menarche and until becoming post-menopausal unless permanently sterile must use adequate contraception. Permanent sterilization methods include hysterectomy, bilateral salpingectomy or bilateral oophorectomy. Adequate contraception in the current study will be the following:

  o Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
  * Intravaginal
  * transdermal
  * Progestogen-only hormonal contraception associated with inhibition of ovulation:
  * oral
  * injectable
  * implantable
  * intrauterine device (IUD)
  * intrauterine hormone-releasing system ( IUS)
  * bilateral tubal occlusion
  * vasectomised partner
  * sexual abstinence
* Patient accept not to receive any other tumor directed treatment before 8 weeks after each 177Lu-PSMA injection.

Exclusion Criteria:

* Estimated GFR \< 30 mL/min
* Platelet count \<75 x109 /L
* White blood cells ≤ 2.5 x 109/L
* Neutrophil count \< 1.5 x109 /L
* Hb \< 8.0 g/dL
* Albumin ≤ 25 g/L
* Uncontrollable symptomatic epilepsy refractory to standard medication
* Pacemakers or defibrillators not compatible with 3T MRI
* No ability to obtain informed consent (e.g. due to severe dysphasia or cognitive deficits).
* Breastfeeding
* Pregnancy
* Hypersensitivity to the active substance or to any of the excipients
* Urinary and fecal incontinence (patient cannot have diaper needs)
* Significant medical or psychiatric illness that, in the investigator's opinion, would compromise the patient's ability to tolerate this therapy
* If previous radiotherapy and/or radionuclide therapy have resulted in absorbed doses \>=23 Gy to any of the kidneys, or \>= 25 Gy to any of the parotids, an individual assessment will be made by the nuclear medicine physician and medical physicist if patient can be included to the therapy part of the study.
* Concurrent investigational drugs or experimental therapy must be stopped at least 4 weeks prior to study entry
* Unwilling to accept potential challenge with xerostomia

Conditions2

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