Theranostics in Soft Tissue Sarcoma Using a Vascular Disruption Approach
NCT ID: NCT05420727
Last Updated: 2024-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
14 participants
INTERVENTIONAL
2023-02-08
2024-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Positive Ga-68-PSMA-11 PET/CT patients treated by Lu-177-ITG-PSMA-1
Positive Ga-68-PSMA-11 PET/CT prior to two cycles of Lu-177-ITG-PSMA-1 i scheduled six weeks apart.
Ga-68-PSMA-11 PET/CT
Ga-68-PSMA-11 PET/CT imaging
Lu-177-ITG-PSMA-1
Lu-177-ITG-PSMA-1 treatment
Interventions
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Ga-68-PSMA-11 PET/CT
Ga-68-PSMA-11 PET/CT imaging
Lu-177-ITG-PSMA-1
Lu-177-ITG-PSMA-1 treatment
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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John O. Prior
OTHER
Responsible Party
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John O. Prior
Head of Nuclear Medicine Department, PhD MD
Principal Investigators
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John O Prior, PhD MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire Vaudois - Lausanne University Hospital
Locations
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Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, Switzerland
Countries
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Other Identifiers
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Theranostics STS
Identifier Type: -
Identifier Source: org_study_id
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