Clincosm LogoSign in Get a demo

ThernSarc: Theranostics in Soft Tissue Sarcoma Using a Vascular Disruption Approach

Sponsor
John O. Prior (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05420727
Collaborator
(none)
20
Enrollment
1
Arm
11
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Theranostics in Soft Tissue Sarcoma Using a Vascular Disruption Approach
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: Ga-68-PSMA-11 PET/CT
Ga-68-PSMA-11 PET/CT imaging

Drug: Lu-177-ITG-PSMA-1
Lu-177-ITG-PSMA-1 treatment

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. SUVmax and radiological changes using PSMA - PET/CT [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) [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • John O. Prior

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
John O. Prior, Head of Nuclear Medicine Department, PhD MD, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT05420727
Other Study ID Numbers:
  • Theranostics STS
First Posted:
Jun 15, 2022
Last Update Posted:
Jul 11, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Sarcoma
Gallium 68 PSMA-11

Study Results

No Results Posted as of Jul 11, 2022