- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00805636
Evaluation of the Efficacy and Safety of [18F]-ML-10, as a PET Imaging Radiotracer, in Early Detection of Response of Brain Metastases of Solid Tumors to Radiation Therapy.
Evaluation of Efficacy and Safety of 18FML10, as a PET Imaging Radiotracer, in Early Detection of Response of Brain Metastases of Non-Hematological Solid Tumors to Radiation Therapy
Study Overview
Status
Conditions
Detailed Description
Early assessment of the efficacy of anti-cancer therapy is highly desirable and an unmet need in clinical oncology. Currently, treatment efficacy is mostly measured by following tumor size by anatomical imaging (CT scan or MRI). However, changes in tumor size may be observed only after several weeks to several months after completion of treatment. Meanwhile, in cases where there is no response, the patient is unnecessarily exposed to treatment's side effects, and precious time may be lost before the initiation of an alternative, potentially more beneficial line of therapy. Therefore, there is an urgent and serious need for better tools for monitoring of tumor response to anti-cancer treatments.
To address this need, [18F]-ML-10, a novel small molecular-weight probe (MW 205) was developed for clinical detection of apoptosis in vivo by positron emission tomography (PET). [18F]-ML-10 is a member of the Aposense family of compounds, a novel class of molecular probes for molecular imaging of cell death. The proposed indication for which [18F]-ML-10 is being developed is for early assessment of response of solid tumors to radiation and chemoradiation therapy.
Previous preclinical and clinical studies have substantiated the safety of [18F]-ML-10, its very high stability in vivo, its favorable biodistribution profile, and its efficacy in clinical detection of cell death. In preclinical studies, the selective retention of [18F]-ML-10 in the focus of the neurovascular cell death in cerebral ischemia was demonstrated in respective animal models. [18F]-ML-10 has been examined in two clinical trials in Uppsala Imanet, Sweden, and has been found safe in administration to healthy subjects and to elderly subjects with acute ischemic cerebral stroke. In these clinical trials, [18F]-ML-10 was also found efficacious in the clinical imaging of apoptosis, being either physiological apoptosis as observed in the testes in young healthy males, and pathological cell death, as observed in the brains of patients with acute ischemic cerebral stroke.
Additional Phase 2 study demonstrated the suitability and safety of 18F-ML-10, designed to serve as a PET radiotracer for early detection of cellular apoptosis of brain metastases in response to WBRT. The relationship between the early change in 18F-ML-10 uptake by the tumor, observed during or upon completion of treatment, and subsequent tumor shrinkage as observed by MRI eight weeks after the completion of WBRT, was demonstrated.18F-ML-10 demonstrated a good safety profile with no drug-related AEs or any effect on safety parameters.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Recruiting
- Dana-Farber Cancer Institute
-
Contact:
- Elysia Larson
- Email: ELARSON@LROC.HARVARD.EDU
-
Principal Investigator:
- Stephanie E Weiss, MD
-
Boston, Massachusetts, United States, 02115
- Recruiting
- Beth Israel Deaconess Medical Center
-
Principal Investigator:
- Eric Wong, MD
-
Contact:
- Juho Whang
- Email: jwhang@bidmc.harvard.edu
-
-
New York
-
New York city, New York, United States, 10065
- Recruiting
- Department of Radiation oncology, Memorial Sloan Kettering Cancer Center
-
Contact:
- Gina Giannantoni-ibelli
- Email: GiannanG@mskcc.org
-
Principal Investigator:
- Kathryn Beal, MD
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15232
- Recruiting
- UPMC Shadyside Radiation Oncology
-
Contact:
- Rhonda Berlin
- Email: berlinrL@upmc.edu
-
Principal Investigator:
- Heron Dwight, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female patients with metastatic non- hematological solid tumors, with one or more brain metastases, of which at least one lesion has a diameter ≥1.5 cm, as confirmed by anatomical imaging (GBCA-enhanced MRI), wherein this lesion (or lesions) is scheduled to be treated by SRS.
- ECOG performance status of 0, 1 or 2 at the time of enrollment.
- Women of child-bearing potential must have a negative blood pregnancy test at screening and use an adequate and medically acceptable contraceptive method.
- Willing and able to follow the protocol requirements.
- Able to provide written informed consent.
Exclusion Criteria:
- Unstable medical condition, such as ischemic heart disease, or any other disease or medical condition that may place the patient at added risk during the study, as assessed by the Principal Investigator. A patient with a seizure disorder, focal or generalized, not adequately controlled by anti-convulsant therapy, and /or patient who have experienced an event of focal or generalized seizure within 7 days prior to screening will be considered neurologically unstable.
- Any indication of a risk for an imminent brain herniation, as evaluated by the Principal Investigator, based on the findings on brain MRI.
- Treatment with whole brain radiation therapy (WBRT) within 3 months prior to screening.
- Evidence for hemorrhage within any of the brain metastases.
- Any known psychiatric disorder other than mild depression or anxiety that may affect adherence to the study requirements.
- Known allergy to gadolinium.
- Any contraindication to MR imaging (e.g., metal implant, aneurysm clip, pacemaker).
- Other condition that, in the opinion of the Investigator, might jeopardize the safety of the patient, or the adequate evaluation of study results.
- Treatment with any investigational drug, device or biologic agent within 30 days prior to administration of [18F]-ML-10.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the relationship between changes in 18FML10 uptake in the target lesions (PET/CT) obtained before and after radiotherapy (SRS), and changes of the lesions size (MRI, ~8w after SRS) in response to treatment, according to the WHO criteria
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Characterization of early alterations in the voxel-based 18FML10 uptake in the target lesion in response to the single fraction high-dose Stereotactic RadioSurgery, SRS. 18FML10 uptake at 24h after SRS and at baseline, before SRS, will be compared
Time Frame: 1 year
|
1 year
|
To identify parameters derived from the changes in 18FML10 uptake observed early after SRS that can discriminate responsive from non-responsive target lesions, and to estimate optimal cut-off values of this parameter (sensitivity and specificity)
Time Frame: 1 year
|
1 year
|
To perform additional analyses for all other lesions with longest diameter ≥ 1.5 cm treated by SRS.
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NST-CA004CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Solid Tumors
-
Incyte CorporationRecruitingA Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid TumorsAdvanced Solid Tumors | Solid Tumors | Metastatic Solid TumorsUnited States, Spain, United Kingdom, France, Italy, Denmark, Switzerland
-
National Cancer Institute (NCI)RecruitingSolid Tumor | Refractory Solid Tumors | Malignant Solid Tumors | Other Neoplasms Solid Tumors | Pediatric Solid TumorUnited States
-
Incyte Biosciences Japan GKCompletedAdvanced Solid Tumors | Metastatic Solid TumorsJapan
-
Memorial Sloan Kettering Cancer CenterKyowa Hakko Kirin Pharma, Inc.CompletedAdvanced Solid Tumors | Metastatic Solid TumorsUnited States
-
Bristol-Myers SquibbCompletedAdvanced Solid Tumors | Metastatic Solid TumorsKorea, Republic of, Canada, Australia
-
Hoffmann-La RocheCompletedSolid Tumors, Advanced Solid TumorsUnited States
-
Esperance Pharmaceuticals IncCompletedAdvanced Solid Tumors | Solid TumorsUnited States
-
NeuPharma, Inc.RecruitingLocally Advanced Solid Tumors | Metastatic Solid TumorsUnited States
-
AmgenCompletedCancer | Advanced Solid Tumors | Solid Tumors | Tumors | Advanced MalignancyUnited States, Australia
-
NantCell, Inc.CompletedQUILT-2.016: Study of AMG 479 With Biologics or Chemotherapy for Subjects With Advanced Solid TumorsCancer | Advanced Solid Tumors | Solid Tumors | Tumors | Advanced Malignancy
Clinical Trials on 2-(5-fluoro-pentyl)-2-methyl-malonic-acid ([18F]-ML-10)
-
Aposense Ltd.TerminatedMetastasis to Brain of Unknown Primary
-
Dana-Farber Cancer InstituteProgenics Pharmaceuticals, Inc.Not yet recruitingProstate Cancer | Metastatic Castration-resistant Prostate Cancer | Metastatic Castration-resistant Prostate CarcinomaUnited States
-
National Cancer Institute (NCI)Active, not recruitingProstate Cancer | Prostatic NeoplasmUnited States
-
Stanford UniversityActive, not recruitingThyroid Cancer | Anaplastic Thyroid Cancer | Undifferentiated Thyroid CancerUnited States
-
AmtixBio Co., Ltd.Novotech (Australia) Pty LimitedCompleted
-
James M Noble, MD, MS, CPH, FAANNational Institute on Aging (NIA)Enrolling by invitation
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Tedec-Meiji Farma, S.A.CompletedOsteoarthritis of the KneeSpain
-
Maastricht Radiation OncologyTerminatedProstatic Neoplasms | Esophageal Neoplasms | Rectal Neoplasms | Brain Neoplasm, Primary | Neoplasm Metastases, BrainNetherlands
-
Stanford UniversityCompleted