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A Study to Demonstrate the Safety and Preliminary Efficacy of 18F-FLT in Patients With Solid Tumours or Lymphoma

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ClinicalTrials.gov Identifier: NCT01065805
Recruitment Status : Unknown
Verified June 2014 by AHS Cancer Control Alberta.
Recruitment status was:  Recruiting
First Posted : February 9, 2010
Last Update Posted : June 12, 2014
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta

Study Description
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Brief Summary:
The Radiotracer 18F-FLT can non-invasively assess excessive cell growth in PET scan images. Tumour growth rate is a useful indicator of tumour aggression and response to treatment. Imaging and measuring the cell growth with 18F-FLT may be useful in monitoring response to anticancer treatment.

Condition or disease Intervention/treatment Phase
Brain Cancer Cancer Solid Tumor Lymphoma Biological: 18F-FLT Phase 1 Phase 2

Detailed Description:
Clinical trial is a combined Phase I/II imaging, open label, single site study in patients with known or suspected carcinoma of the lung, breast, renal cell, pancreas or brain, and with gastrointestinal malignancies, neuroendocrine tumours, or lymphoma. One 18F-FLT PET scan will be performed in 10 Phase I patients, and pre-injection and post-imaging blood work and vital signs will be collected. Up to 5 18F-FLT PET scans will be performed in 170 Phase II patients.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Contiguous, Sequential Phase I/II Imaging Study of 18F-fluoro-3'-L-fluorothymidine (18F-FLT)in Patients With Known or Suspected Carcinoma of the Lung, Breast, Renal Cell, Pancreas, or Brain, and With Gastrointestinal Malignancies, Neuroendocrine Tumours or Lymphoma
Study Start Date : February 2009
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
18F-FLT PET
 Biological: 18F-FLT

Phase I: Radioactive dose of 2.59 MBq/kg (111-222 MGq)per injection. A single injection of 18F-FLT and PET scan will be permitted per patient.

Phase II: Radioactive dose of 2.59 MBq/kg (100-350) MBq per injection. Up to five separate injections of 18F-FLT and PET scans will be permitted per patient


Outcome Measures
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Primary Outcome Measures :
  1. Phase I: to determine the safety of 18 F-FLT. [ Time Frame: 3 years ]
  2. Phase II: To determine general biodistribution of 18F-FLT and correlate 18F-FLT uptake with hENT1 expression and Ki-67 scores. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Phase I: To determine general biodistribution of 19F-FLT [ Time Frame: 3 years ]
  2. Phase II: to confirm safety of 18F-FLT; to determine the relative uptake of 18F-FLT (SUV, RUS, T/N); and to correlate 18F-FLT uptake with patient outcomes. [ Time Frame: 3 years ]
  3. Phase II: to correlate 18F-FLT uptake with patient outcomes (treatment response, progression-free survival, overall survival), over the first 12 months of follow-up after completion of tx, subsequently over the remainder of the disease course [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female greater than or equal to 16 years of age. If female of child-bearing potential and outside of the window of 10 days since the first day of last menstrual period, a negative pregnancy test is required.
  • Patients with known primary or suspected primary, recurrent or metastatic carcinoma of the lung, breast, renal cell, pancreas or brain (including GGM, oligodendrogliomas, and brain metastases from any primary tumour) and with gastrointestinal malignancies, neuroendocrine tumours (including carcinoid and islet cell malignancies, or lymphoma, with at least one lesion >1 cm in diameter.
  • Biochemical parameters as measured are required to be within 5 times the normal limits for age.
  • Able and willing to follow instruction and comply with the protocol
  • Provide written informed consent prior to participation in the study
  • Karnofsky Performance Scale Score 50-100

Exclusion Criteria:

  • Previous removal of entire tumour
  • Biochemical parameters as measured outside 5 times the normal limits for age
  • Unable or unwilling to follow instructions and comply with the protocol
  • Unable or unwilling to provide written informed consent prior to participation in the study
  • Karnofsky Performance Scale Score < 50
  • Nursing or pregnant females
  • Age less than 16 years
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01065805


Contacts
Contact: Lai Schrader (780) 432 - 8464 Lai.Schrader@albertahealthservices.ca

Locations
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Principal Investigator: Alexander J. B. McEwan, MD         
Sub-Investigator: M ichael B Sawyer, MD         
Sub-Investigator: Andrew R Belch, MD         
Sub-Investigator: John Mercer, BSc, MSc, PhD         
Sub-Investigator: Emmanuel Hudson, BMedSc, MD         
Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
Principal Investigator: Alexander J. B. McEwan, MB, BS, MSc Cross Cancer Institute
More Information
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Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT01065805     History of Changes
Other Study ID Numbers: SP-24513/DX-FLT-002
First Posted: February 9, 2010    Key Record Dates
Last Update Posted: June 12, 2014
Last Verified: June 2014

Keywords provided by AHS Cancer Control Alberta:
18F-FLT
Positive Emission Tomography
Cancer

Additional relevant MeSH terms:
Lymphoma
Brain Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Central Nervous System Neoplasms
 Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Alovudine
Antiviral Agents
Anti-Infective Agents