Relevance Evaluation of [68Ga]Ga-PentixaFor for Initial Staging and Detection of Minimal Residual Disease in Multiple Myeloma Patients.

NCT ID: NCT05321862

Last Updated: 2023-11-15

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-14

Study Completion Date

2023-05-04

Brief Summary

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The aim of our study is to confirm the relevance of PET using \[68Ga\]Ga-PentixaFor ligand, in comparison with FDG, for initial staging and detection of minimal residual disease in multiple myeloma patients eligible for autologous stem cell transplantation less than 66 years.

The prognostic value of positive CXCR4 expression will also be assessed and \[68Ga\]Ga-PentixaFor/FDG discordances explored.

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Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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[68Ga]Ga-PentixaFor

Group Type EXPERIMENTAL

[68Ga]Ga-PentixaFor

Intervention Type DRUG

Tomography by Emission of Positons (PET) with the radiopharmaceutic \[68Ga\]Ga-PentixaFor

Interventions

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[68Ga]Ga-PentixaFor

Tomography by Emission of Positons (PET) with the radiopharmaceutic \[68Ga\]Ga-PentixaFor

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. eGFR \< 50 ml/min by MDRD or CKDEPI.
2. Previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin, curatively treated in situ carcinoma of the cervix, curatively treated solid cancer, with no evidence of disease for at least 2 years.
3. Patient with uncontrolled insulin-dependent or non-insulin-dependent diabetes mellitus.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Nantes

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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RC22_0150

Identifier Type: -

Identifier Source: org_study_id

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