- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01260480
An Efficacy and Safety Study to Assess [18F]-ML-10 in Detecting Response of Tumors to Chemotherapy and Radiation
A Prospective, Multicenter Study, to Evaluate the Efficacy and Safety of [18F]-ML-10, a Positron Emission Tomography (PET) Imaging Radiotracer, in Early Detection of Response of Non-Hematological Tumors to Concurrent Chemoradiotherapy
The purpose of this study is to determine whether [18F]-ML-10 used in conjunction with PET imaging is effective as an imaging tool for the early detection of response of oncological tumors in the lungs,head and neck to chemoradiation therapy.
The study will evaluate the potential of [18F]-ML-10 used in conjunction with PET imaging to distinguish early during the course of chemoradiation therapy between a tumor that responds to the therapy, and a tumor that does not respond to the therapy. Currently, this distinction is available to the physician several weeks or months after completion of therapy, using anatomical imaging (for example Computed Tomography [CT] or Magnetic Resonance Imaging [MRI]).
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States
- Recruiting
- BWH
-
Contact:
- David Sher, MD
- Email: DSHER@PARTNERS.ORG
-
-
New Jersey
-
Teaneck, New Jersey, United States, 07666
- Recruiting
- Holy Name Medical Center
-
Contact:
- Benjamin Rosenbluth, MD
- Email: rosenbluth@mail.holyname.org
-
-
New York
-
New York, New York, United States, 10029
- Recruiting
- Mount Sinai
-
Contact:
- Lale Kostakoglu, MD, MPH
- Email: lale.kostakoglu@msnyuhealth.org
-
-
Pennsylvania
-
Pittsburgh,, Pennsylvania, United States, 15232
- Recruiting
- University of Pittsburgh
-
Contact:
- Heron Dwight, MD
- Phone Number: 412-623-1275
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Male or female patients with either:
Newly diagnosed non small cell lung cancer (NSCLC) (Group A) who meet the following criteria:
- Previously untreated, histologically or cytologically confirmed stage IIB, IIIA or IIIB disease, without evidence of distant metastases
- A measurable primary tumor with at least one diameter > 2 cm or primary tumor extending to one or more lymph nodes which cannot be distinctively delineated as confirmed by a diagnostic quality chest CT performed within 4 weeks prior to initiation of the concurrent CRT.
- Planned to receive concurrent chemoradiotherapy as definitive treatment. The radiation dose should not exceed 70 Gy.
Undergone the following minimum workup to confirm disease staging within 4 weeks prior to initiation of the concurrent CRT:
- GBCA-enhanced Brain MRI or contrast enhanced CT if there are signs or symptoms suggesting brain metastases within the past 2 months.
- If necessary to confirm stage of disease, an upper abdomen CT scan will be performed.
- whole-body FDG PET/CT; OR
Newly diagnosed squamous cell carcinoma of the head and neck (SCCHN) (Group B) who meet the following criteria:
- Previously untreated, histologically or cytologically confirmed (from the primary tumor and/or lymph nodes) stage III-IV disease without evidence of distant metastases.
- A measurable (i) primary tumor with at least one diameter ≥2 cm and (ii) lymph node with at least one diameter ≥ 2 cm as confirmed by a diagnostic quality neck CT performed within 4 weeks prior to initiation of the concurrent CRT.
- Planned to receive concurrent chemoradiotherapy as definitive treatment. The radiation dose should not exceed 70 Gy.
- Have undergone the following minimum workup to confirm disease staging within 4 weeks prior to initiation of the concurrent CRT:
- Whole-body FDG PET/CT.
- Patients ≥ 18 years of age.
- Able to comply with lying still during the PET/CT imaging session which may last for up to 3 hrs with intermediate breaks.
- ECOG performance status of 0, 1 or 2.
- Adequate renal function and adequate hepatic function, as assessed by standard laboratory criteria and defined as:
- Serum creatinine ≤ 1.2 times the Upper Limit of Normal (ULN).
- Total bilirubin ≤ 1.5 times the ULN.
- Asparagine aminotransferase (AST) and/or alanineaminotransferase (ALT) ≤ 2.5 times the ULN (grade 1 according to the NCI-CTCAE v.3).
- 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 comply with the protocol requirements.
- Able to provide written informed consent.
Exclusion Criteria:
Exclusion criteria specific to patients with NSCLC (Group A):
- Predominant small cell carcinoma histology.
- Pure bronchioalveolar cell carcinoma histology.
- Treatment planned with chemotherapy other than a platinum-based doublet regimen.
- Malignant pleural or pericardial effusions.
- Any contraindication to perform CT with IV contrast agent.
Exclusion criteria specific to patients with SCCHN (Group B):
- Histology other than squamous cell carcinoma.
- Treatment planned with chemotherapy other than a platinum-based regimen.
- Treatment planned with cetuximab.
- Treatment with induction chemotherapy.
- Any contraindication to CT with IV contrast agent.
- Evidence of distant metastases.
- Patients who, based on the investigator's judgment, have other unstable medical conditions that may preclude safe and complete study participation.
- Treatment with any investigational drug, device or biologic agent within 30 days prior to administration of [18F]-ML-10.
- Pregnancy or lactation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: [18F]-ML-10
|
Subjects will receive two to three intravenous (IV) doses of [18F]-ML-10.
The dose for each [18F]-ML-10 dose will be 5.50 MBq/Kg or 0.15 mCi/Kg but will not exceed 500.00
MBq (13.50 mCi) per administration.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To characterize changes in [18F]-ML-10 uptake in the target lesion in response to chemoradiotherapy.
Time Frame: Between baseline and day 11 ± 1, and between baseline and day 18 ± 1
|
Between baseline and day 11 ± 1, and between baseline and day 18 ± 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
---|---|
To assess the correlation between the changes in the uptake of [18F]-ML-10 in the target lesion and the changes in the anatomical dimensions of the target lesion.
|
To assess the correlation between the changes in the uptake of [18F]-ML-10 in the target lesion following an accumulative radiation dose of 14.4-20.0
Gy, and the changes in the anatomical dimensions of the target lesion, as assessed by the follow-up anatomical imaging by CT, performed after completion of the concurrent chemoradiotherapy (CRT).
|
To identify at least one parameter, derived from the changes in [18F]-ML-10 uptake that can discriminate tumors responsive to treatment from tumors that are non-responsive.
|
For this parameter, various cut-off values of change will be evaluated, with corresponding estimates of sensitivity and specificity.
|
To perform additional analyses for all other lesions and lymph nodes with at least one diameter ≥ 2 cm treated by concurrent CRT.
|
|
To assess the safety of [18F]-ML-10 administered to cancer patients receiving concurrent CRT.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Heron Dwight, MD, University of Pittsburgh Medical Center
- Principal Investigator: David Sher, MD, MPH, BWH, Harvard
- Study Director: Aaron Allen, MD, Rabin Medical Center
Study record dates
Study Major Dates
Study Start
Primary 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-CA007
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 Head and Neck Neoplasms
-
Robert FerrisAmgenCompletedHead and Neck Cancer | Cancer of Head and Neck | Head Cancer | Neck Cancer | Neoplasms, Head and Neck | Cancer of the Head and Neck | Cancer of Neck | Upper Aerodigestive Tract Neoplasms | Neck Neoplasms | Cancer of the Head | Cancer of the Neck | UADT Neoplasms | Cancer of Head | Head Neoplasms | Head, Neck Neoplasms | Neoplasms, Head and other conditionsUnited States
-
Assiut UniversityRecruitingHead and Neck Cancer | Head and Neck Neoplasms | Cancer of Head and Neck | Neoplasms, Head and Neck | Cancer of the Head and NeckEgypt
-
IRCCS Policlinico S. MatteoNestlé Health Science Spain; Akern SrlCompletedHead-neck CancerItaly
-
University of California, San FranciscoCompleted
-
IntraGel TherapeuticsNot yet recruiting
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingHead and Neck CarcinomaUnited States
-
Gustave Roussy, Cancer Campus, Grand ParisActive, not recruiting
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Completed
-
Jonsson Comprehensive Cancer CenterWithdrawnHead and Neck CarcinomaUnited States
-
OHSU Knight Cancer InstituteNational Cancer Institute (NCI)WithdrawnHead and Neck CarcinomaUnited States
Clinical Trials on [18F]-ML-10 in conjunction with PET imaging
-
Aposense Ltd.CompletedSolid Tumors | Brain Metastases
-
Nicole HillBlue Earth Diagnostics; Barrow Neurological FoundationRecruitingGrade III or Grade IV GliomaUnited States
-
Martin DichgansUniversity Hospital Muenster; Universitätsklinikum Hamburg-EppendorfRecruiting
-
Vanderbilt-Ingram Cancer CenterCompletedRectal CancerUnited States
-
Alan NicholCompletedCancer (High-grace Glioma)Canada
-
University Hospital, BordeauxRecruiting
-
Sidney Kimmel Comprehensive Cancer Center at Johns...National Cancer Institute (NCI); National Institutes of Health (NIH)Recruiting
-
University of Wisconsin, MadisonTerminatedHead and Neck Cancer | Esophageal Cancer | Lung Cancer | Prostate Cancer | CNS Brain MetastasisUnited States
-
CHDI Foundation, Inc.CompletedHuntington's DiseaseSweden, Denmark, Netherlands, Norway
-
Mayo ClinicBlue Earth Diagnostics, IncRecruitingMetastatic Intracranial Malignant Neoplasm | Recurrent Intracranial NeoplasmUnited States