Study Stopped
MIDAS inclusions terminated before first inclusion in PENTI-MIDAS
Relevance Evaluation of [68Ga]Ga-PentixaFor for Initial Staging and Detection of Minimal Residual Disease in Multiple Myeloma Patients.
PENTI-MIDAS
Exploratory Study Evaluating the Relevance of [68Ga]Ga-PentixaFor for Initial Staging and Detection of Minimal Residual Disease in Multiple Myeloma Patients Eligible for Autologous Stem Cell Transplantation Less Than 66 Years Included in the Prospective IFM 2020-02.
1 other identifier
interventional
N/A
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2023
Shorter than P25 for phase_2 multiple-myeloma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2022
CompletedFirst Posted
Study publicly available on registry
April 11, 2022
CompletedStudy Start
First participant enrolled
March 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 4, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 4, 2023
CompletedNovember 15, 2023
November 1, 2023
2 months
March 24, 2022
November 13, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Sensitivity
To determine the sensitivity of \[68Ga\]Ga-PentixaFor-PET to detect Multiple Myeloma lesions \[Bone marrow (BM) lesions and/or extra-medullary disease (EMD)\] at the time of initial diagnosis in high risk MM patients included in the MIDAS study.
6 months
Secondary Outcomes (8)
Specificity, positive predictive value (PPV) and negative predictive value (NPV) of [68Ga]Ga-PentixaFor-PET.
1 month
Prognostic impact of FDG-PET and of [68Ga]Ga-PentixaFor-PET depending on the uptake detected by each imaging technique.
1 month
Discrepancies rate between FDG-PET and [68Ga]Ga-PentixaFor-PET and factors associated with.
1 month and 6 months
Correlation between FDG-PET and [68Ga]Ga-PentixaFor-PET uptakes evaluated by SUV.
1 month
Correlation between FDG-PET and [68Ga]Ga-PentixaFor-PET uptakes evaluated by the RNAseq data evaluated on the myelogram.
1 month
- +3 more secondary outcomes
Study Arms (1)
[68Ga]Ga-PentixaFor
EXPERIMENTALInterventions
Tomography by Emission of Positons (PET) with the radiopharmaceutic \[68Ga\]Ga-PentixaFor
Eligibility Criteria
You may not qualify if:
- eGFR \< 50 ml/min by MDRD or CKDEPI.
- 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.
- Patient with uncontrolled insulin-dependent or non-insulin-dependent diabetes mellitus.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Nantes
Nantes, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2022
First Posted
April 11, 2022
Study Start
March 14, 2023
Primary Completion
May 4, 2023
Study Completion
May 4, 2023
Last Updated
November 15, 2023
Record last verified: 2023-11