Clinical trial NCT01065805: A Study to Demonstrate the Safety and Preliminary Efficacy of 18F-FLT in Patients With Solid Tumours or Lymphoma
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Brain Cancer
Cancer
Solid Tumor
Lymphoma
Keywords: 18F-FLT
Positive Emission Tomography
Cancer
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2010-02-09
Enrollment: 94
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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

Primary outcomes:
measure: Phase I: to determine the safety of 18 F-FLT.
timeFrame: 3 years
measure: Phase II: To determine general biodistribution of 18F-FLT and correlate 18F-FLT uptake with hENT1 expression and Ki-67 scores.
timeFrame: 3 years
Secondary outcomes:
measure: Phase I: To determine general biodistribution of 19F-FLT
timeFrame: 3 years
measure: 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.
timeFrame: 3 years
measure: 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
timeFrame: 3 years
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: Cross Cancer Institute
name: Michael B Sawyer, MD
role: PRINCIPAL_INVESTIGATOR
References: