NCT00935090

Brief Summary

RATIONALE: Diagnostic procedures, such as 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) PET imaging, may help find and diagnose cancer. It may also help doctors predict a patient's response to treatment and help plan the best treatment. PURPOSE: This phase I trial is studying FLT PET imaging in patients with cancer.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
24mo left

Started Sep 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Sep 2009May 2028

First Submitted

Initial submission to the registry

July 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 8, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
17.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

July 8, 2025

Status Verified

July 1, 2025

Enrollment Period

17.7 years

First QC Date

July 7, 2009

Last Update Submit

July 2, 2025

Conditions

Brain and Central Nervous System TumorsChronic Myeloproliferative DisordersLeukemiaLymphomaLymphoproliferative DisorderMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative NeoplasmsUnspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specificaccelerated phase chronic myelogenous leukemiaacute undifferentiated leukemiaadult acute lymphoblastic leukemia in remissionadult acute myeloid leukemia in remissionadult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with t(15;17)(q22;q12)adult acute myeloid leukemia with t(16;16)(p13;q22)adult acute myeloid leukemia with t(8;21)(q22;q22)atypical chronic myeloid leukemia, BCR-ABL negativeblastic phase chronic myelogenous leukemiachronic myelomonocytic leukemiachronic phase chronic myelogenous leukemiamast cell leukemiameningeal chronic myelogenous leukemiaprogressive hairy cell leukemia, initial treatmentprolymphocytic leukemiarecurrent adult acute lymphoblastic leukemiarecurrent adult acute myeloid leukemiarecurrent adult T-cell leukemia/lymphomarefractory chronic lymphocytic leukemiarefractory hairy cell leukemiarelapsing chronic myelogenous leukemiasecondary acute myeloid leukemiastage I adult T-cell leukemia/lymphomastage I chronic lymphocytic leukemiastage II adult T-cell leukemia/lymphomastage II chronic lymphocytic leukemiastage III adult T-cell leukemia/lymphomastage III chronic lymphocytic leukemiastage IV adult T-cell leukemia/lymphomastage IV chronic lymphocytic leukemiaT-cell large granular lymphocyte leukemiauntreated adult acute lymphoblastic leukemiauntreated adult acute myeloid leukemiauntreated hairy cell leukemiarecurrent adult Hodgkin lymphomastage I adult Hodgkin lymphomastage II adult Hodgkin lymphomastage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomaanaplastic large cell lymphomaangioimmunoblastic T-cell lymphomacutaneous B-cell non-Hodgkin lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomastage I cutaneous T-cell non-Hodgkin lymphomastage II cutaneous T-cell non-Hodgkin lymphomastage III cutaneous T-cell non-Hodgkin lymphomastage IV cutaneous T-cell non-Hodgkin lymphomarecurrent mycosis fungoides/Sezary syndromestage I mycosis fungoides/Sezary syndromestage II mycosis fungoides/Sezary syndromestage III mycosis fungoides/Sezary syndromestage IV mycosis fungoides/Sezary syndromeadult grade III lymphomatoid granulomatosisadult nasal type extranodal NK/T-cell lymphomaWaldenstrom macroglobulinemiaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomacontiguous stage II adult Burkitt lymphomacontiguous stage II adult diffuse large cell lymphomacontiguous stage II adult diffuse mixed cell lymphomacontiguous stage II adult diffuse small cleaved cell lymphomacontiguous stage II adult immunoblastic large cell lymphomacontiguous stage II adult lymphoblastic lymphomacontiguous stage II grade 1 follicular lymphomacontiguous stage II grade 2 follicular lymphomacontiguous stage II grade 3 follicular lymphomacontiguous stage II mantle cell lymphomacontiguous stage II marginal zone lymphomacontiguous stage II small lymphocytic lymphomastage I adult Burkitt lymphomastage I adult diffuse large cell lymphomastage I adult diffuse mixed cell lymphomastage I adult diffuse small cleaved cell lymphomastage I adult immunoblastic large cell lymphomastage I adult lymphoblastic lymphomastage I grade 1 follicular lymphomastage I grade 2 follicular lymphomastage I grade 3 follicular lymphomastage I mantle cell lymphomastage I marginal zone lymphomastage I small lymphocytic lymphomanoncontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomanoncontiguous stage II mantle cell lymphomanoncontiguous stage II marginal zone lymphomanoncontiguous stage II small lymphocytic lymphomastage III adult Burkitt lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse small cleaved cell lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III mantle cell lymphomastage III marginal zone lymphomastage III small lymphocytic lymphomastage IV adult Burkitt lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV mantle cell lymphomastage IV marginal zone lymphomastage IV small lymphocytic lymphomarecurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult grade III lymphomatoid granulomatosisrecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaintraocular lymphomaprimary central nervous system non-Hodgkin lymphomaprimary central nervous system Hodgkin lymphomapost-transplant lymphoproliferative disorderchronic eosinophilic leukemiachronic neutrophilic leukemiaprimary myelofibrosisessential thrombocythemiapolycythemia veraextramedullary plasmacytomaisolated plasmacytoma of bonestage I multiple myelomastage II multiple myelomastage III multiple myelomaprimary systemic amyloidosisrefractory multiple myelomade novo myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesmyelodysplastic/myeloproliferative neoplasm, unclassifiable

Outcome Measures

Primary Outcomes (2)

  • Measurement of the uptake and retention of 3'-deoxy-3'-[18F] fluorothymidine (FLT) in tumors and normal organs

    at time of PET or CT PET Scan

  • Changes in thymidine kinase, thymidylate synthase, and standardized uptake values

    before and after therapy

Secondary Outcomes (1)

  • FLT PET response rate

    up to 2 hours during PET scan

Study Arms (1)

3'-deoxy-3'-[18F]fluorothymidine

EXPERIMENTAL

The PET scan data collection is started immediately and is continued for 2 hours. This procedure will measure tumor growth within the body.

Device: 3'-deoxy-3'-[18F]fluorothymidine

Interventions

3'-deoxy-3'-[18F]fluorothymidineDEVICE

The tracer compound \[F-18\] FLT will be injected into the patient's veins in a small volume of normal saline solution. The PET scan data collection is started immediately and is continued for 2 hours. This procedure will measure tumor growth within the body. Blood may be withdrawn (through the catheters) up to a total volume of 30 milliliters (or 2 tablespoons) for each scan. A urine sample may be collected at the end of the imaging of the tracer compound to analyze its breakdown products.

Also known as: PET Scan
3'-deoxy-3'-[18F]fluorothymidine

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Meets one of the following criteria: * Histologically confirmed solid tumor or hematologic malignancy * Awaiting biopsy or surgery for cancer evaluation of a mass detected on exam or standard imaging PATIENT CHARACTERISTICS: * Able to lie still in the PET scanner * Girth and weight must be suitable to enter the gantry * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Central Nervous System NeoplasmsMyeloproliferative DisordersLeukemiaLymphomaLymphoproliferative DisordersMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesLeukemia, Myeloid, Accelerated PhaseLeukemia, Biphenotypic, AcuteCongenital AbnormalitiesLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeBlast CrisisLeukemia, Myelomonocytic, ChronicLeukemia, Myeloid, Chronic-PhaseLeukemia, Mast-CellLeukemia, ProlymphocyticPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcutePrecursor T-Cell Lymphoblastic Leukemia-LymphomaLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Hairy CellLeukemia, Large Granular LymphocyticHodgkin DiseaseLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyLymphoma, T-Cell, CutaneousMycosis FungoidesSezary SyndromeLymphoma, Extranodal NK-T-CellWaldenstrom MacroglobulinemiaLymphoma, B-Cell, Marginal ZoneBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticLymphoma, FollicularLymphoma, Mantle-CellIntraocular LymphomaPdgfra-Associated Chronic Eosinophilic LeukemiaLeukemia, Neutrophilic, ChronicPrimary MyelofibrosisThrombocythemia, EssentialPolycythemia VeraImmunoglobulin Light-chain Amyloidosis

Interventions

Positron-Emission Tomography

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, LymphoidCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesMastocytosis, SystemicMastocytosisMast Cell Activation DisordersLeukemia, B-CellLeukemia, T-CellLymphoma, T-CellLymphadenopathyLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsEye NeoplasmsBlood Coagulation DisordersThrombocytosisBlood Platelet DisordersBone Marrow NeoplasmsHematologic NeoplasmsAmyloidosisProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Tomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisImage EnhancementPhotographyRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Officials

  • Anthony F. Shields, MD, PhD

    Barbara Ann Karmanos Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 7, 2009

First Posted

July 8, 2009

Study Start

September 1, 2009

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2028

Last Updated

July 8, 2025

Record last verified: 2025-07

Locations

US(1)