Theranostics in Soft Tissue Sarcoma Using a Vascular Disruption Approach

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05420727

Studienbeginn:
Februar 2023

Letztes Update:
03.02.2023

Wirkstoff:
Ga-68-PSMA-11 PET/CT, Lu-177-ITG-PSMA-1

Indikation (Clinical Trials):
Sarcoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
John O. Prior

Collaborator:
-

Studienleiter

John O Prior, PhD MD
Principal Investigator
Centre Hospitalier Universitaire Vaudois - Lausanne University Hospital

Kontakt

John O Prior, PhD MD
Kontakt:
Phone: +41795568702
E-Mail: john.prior@chuv.ch» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Centre Hospitalier Universitaire Vaudois
1011 Lausanne
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
John O. Prior, MD, PhD
Phone: +41 (0)21-3144348
E-Mail: john.prior@chuv.ch» Ansprechpartner anzeigen

Studien-Informationen

Brief Summary:

To test the feasibility of theranostic targeting the PSMA receptor in STS patients by

Ga-68-PSMA-11 PET/CT and Lu-177-ITG-PSMA-1 treat-ment with special emphasis on vascular

disruption using a translational approach.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Female or male ≥ 18 years old at the time of informed consent

- Patients with proven Soft Tissue Sarcoma

- Patients need to pass the sarcoma tumor board and the molecular tumor board at CHUV

and no approved therapeutic alternative is available

- Progression of the disease by RECIST v1.1 after standard therapies according to the

treat-ing oncologists

- Informed Consent as documented by signed informed consent form

Exclusion Criteria:

- Patients under active anti-sarcoma treatment other than the study product

(Lu-177-ITG-PSMA-1)

- Female participants who are pregnant or breast feeding

- Female participants with intention to become pregnant during the course of the study

- Lack of safe contraception, defined as: Female participants of childbearing potential,

not us-ing and not willing to continue using a medically reliable method of

contraception for the en-tire study duration until 6 months after last

Lu-177-ITG-PSMA-1 treatment, such as oral, in-jectable, or implantable contraceptives,

or intrauterine contraceptive devices, or who are not using any other method

considered sufficiently reliable by the investigator in individual cases. Male

patients of reproductive potential, not using and not willing to use a medically

reliable method of contraception for the entire study duration until 6 months after

last Lu-177-ITG-PSMA-1 treatment, such as barrier method or sexual abstinence or who

are not using any other method considered sufficiently reliable by the investigator in

individual cases. The par-ticipant must inform their female partners about the

participation in this trial and they must use additional effective contraception

(e.g., hormonal) during the trial until 6 months after the last Lu-177-ITG-PSMA-1

treatment.

- Previous enrolment into the current study

- History of any disease or relevant physical condition or abnormal physical finding

which may interfere with the study objectives at the investigator judgment

- Insufficient knowledge of project language, inability to give consent or to follow

procedures, incapacity to follow radiation safety procedures, required by the study

- Enrolment of the investigator, his/her family members, employees and other dependent

per-sons

- The patient makes use of his/her "right not to know" and refuses to be informed about

inci-dental findings

- Absence of PSMA accumulation in at least 50% of tumours on Ga-68-PSMA-11 PET/CT

- Grade IV renal impairment and above (calculated GFR < 30 mL/min/1.73 m2)

- Blood count disturbance:

Platelets < 75,000/µL. Leukocytes < 2,500/µL Haemoglobin < 80 g/L. • Disturbance of liver

function with: Total bilirubin > 2 times the upper limit of the norm ASAT/ALAT > 3 times

the upper limit without the presence of liver metastases ASAT/ALAT > 5 times the upper

limit in the presence of liver metastases

• Hypersensitivity to any of the ingredients of the injectable product

Studien-Rationale

Primary outcome:

1. imaging result obtained by Ga-68-PSMA-11 PET/CT (Time Frame - four weeks after the second cycle of Lu-177-ITG-PSMA-1 treatment, compared to base-line)

Secondary outcome:

1. SUVmax and radiological changes using PSMA - PET/CT (Time Frame - four weeks after the second cycle of Lu-177-ITG-PSMA-1 treatment, compared to base-line.):
SUVmax and radiological changes using PSMA - PET/CT using advanced radiological assessment including CHOI criteria to as-sess the necrosis one month after end of second cycle

2. Tumor evaluation using contrast enhanced computed tomography (ceCT) (Time Frame - four weeks after the second cycle of Lu-177-ITG-PSMA-1 treatment, compared to base-line.):
Tumor evaluation using contrast enhanced computed tomography (ceCT) using RECIST v1.1 (change in tumor size in mm)

Geprüfte Regime

Ga-68-PSMA-11 PET/CT:
Ga-68-PSMA-11 PET/CT imaging
Lu-177-ITG-PSMA-1:
Lu-177-ITG-PSMA-1 treatment

Quelle: ClinicalTrials.gov

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