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
1 other identifier
interventional
30
1 country
4
Brief Summary
The purpose of this study is to evaluate the potential of \[18F\]-ML-10 to serve as an imaging tool for the early detection of response of brain metastases to radiation therapy. Such early detection may help early identification of responsive and non-responsive lesions. The experimental design of the present study aims to evaluate the potential of PET imaging with \[18F\]-ML-10 to address the currently unmet clinical need for very early (within one day)assessment of response to therapy. Currently, response assessment is available only after several weeks or months after completion of therapy, when tumor shrinkage can be detected by anatomical imaging (by MRI). Early detection of tumor response to treatment is now widely-recognized as a highly-desirable goal in oncology, and is respectively the target of intense research worldwide. In the future, the option to know early upon treatment administration, that the treated tumor is a non-responsive, may improve clinical management of patients with brain metastases of solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2008
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 7, 2008
CompletedFirst Posted
Study publicly available on registry
December 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedMay 12, 2010
April 1, 2010
1.9 years
December 7, 2008
May 11, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
1 year
Secondary Outcomes (3)
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
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)
1 year
To perform additional analyses for all other lesions with longest diameter ≥ 1.5 cm treated by SRS.
1 year
Interventions
\[18F\]-ML-10 will be radiolabeled at the PET Radioactive Drug Production (RDP) facility at or in close proximity to each clinical site, and will be administered as an intravenous bolus injection (in 3-10 ml sterile saline solution, containing no more than 10% ethanol by volume). The dose concentration selected for \[18F\]-ML-10 will be 7 MBq/Kg or 0.19 mCi/Kg. The radioactivity dosage of \[18F\]-ML-10 administered at each PET/CT session will be at least 300 MBq (8.1 mCi) and not more than 500 MBq (13.5 mCi).
SRS will be administered according to the standard of care using a radiation dose of 14-24 Gy to each lesion.
Each patient will undergo 2 PET/CT sessions, each following intravenous administration of \[18F\]-ML-10, to assess tracer uptake by the brain metastases treated by SRS. The PET/CT scan will be directed to the brain and will include one bed position. The PET/CT sessions will be performed at baseline, i.e., before the radiation treatment, and on the day after, within 24h after SRS treatment.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aposense Ltd.lead
Study Sites (4)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Department of Radiation oncology, Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
UPMC Shadyside Radiation Oncology
Pittsburgh, Pennsylvania, 15232, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 7, 2008
First Posted
December 9, 2008
Study Start
November 1, 2008
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
May 12, 2010
Record last verified: 2010-04