NCT02042924 · REGISTRY CONDITION SEARCH

Pilot Study of Multi-Modality Imaging in Patients With Hematologic Malignancies

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: TERMINATED
Registry last update: 2017-12-05

This is a pilot sub-study of patients receiving myeloablative transplant using total body irradiation (TBI) or total marrow irradiation (TMI) in their preparative regimen. The objective of this stub-study is to estimate the heterogeneity in cellular proliferation (FLT-PET uptake) as well the heterogeneity in marrow composition distribution (measured using whole body water-fat MRI) using positron emission tomography imaging. This will be used to design future trials as well as to determine the feasibility of PET and MRI imaging.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Difference in Percentage of Proliferating Bone Marrow Between Baseline and 100 Days

→

outcome · POSTED

Difference in Water Fat

→

outcome · POSTED

Percentage of Proliferating Bone Marrow in the Femur

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

eligibility Criteria: Inclusion Criteria: * Diagnosis of hematologic malignancy and fitting into one of the following categories: * Newly diagnosed and/or day 14 post-induction chemotherapy * Relapsed, including relapse after hematopoietic cell transplant * Planned hematopoietic cell transplant (if enrolling at "close") or within 100 days post hematopoietic cell transplant (if enrolling post-transplant) with a preparative regimen that includes either total marrow irradiation (TMI) or total body irradiation (TBI) * Undergoing natural killer cell therapies (with or without subsequent transplant) * Aged 18 years and older * Not pregnant - women of childbearing potential will have a confirmatory pregnancy test prior to each imaging per routine procedures * Adequate renal function (estimated glomerular filtration rate \> 60 ml/min) as determined by a serum creatinine level performed as a part of standard of care within 7 days of imaging * Able and willing to provide written consent Exclusion Criteria: * Otherwise eligible patients meeting one or more of the contraindicates for an MRI, may enroll in the study without undergoing the MRI: * ferromagnetic implants * history of shrapnel or shot gun injury * too large to fit in the magnet (approximate body mass index ≥ 40) * cardiac pacemakers or other implanted devices that are not MR-compatible * claustrophobia * large tattoos
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Subjects will have a FLT PET/CT and a MRI prior to starting the preparative regimen for transplant and another of each scan 100 days after transplant.
intervention Names
Radiation: FLT PET/CT
Device: MRI
label
Imaging studies
type
EXPERIMENTAL

interventions

arm Group Labels
Imaging studies
description
Functional marrow imaging using the FLT PET/CT will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).
name
FLT PET/CT
type
RADIATION
arm Group Labels
Imaging studies
description
MRI imaging will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).
name
MRI
type
DEVICE

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

DIAGNOSTIC

Enrollment

count: 2
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
The difference in percentage of proliferating bone marrow will be calculated for the following sites: skull, proximal humeri, ribs, clavicles, cervical spine, thoracic spine, lumbar spine, sacrum, pelvis and proximal femur.
measure
Difference in Percentage of Proliferating Bone Marrow Between Baseline and 100 Days
time Frame
100 days
description
The difference in the water-fat MRI between baseline and day 100 post transplant in L4 and femoral neck.
measure
Difference in Water Fat
time Frame
100 days
description
The difference in the percentage of proliferating bone marrow between baseline and day 100 post transplant in the femur
measure
Percentage of Proliferating Bone Marrow in the Femur
time Frame
100 days

Full study description

brief Summary: This is a pilot sub-study of patients receiving myeloablative transplant using total body irradiation (TBI) or total marrow irradiation (TMI) in their preparative regimen. The objective of this stub-study is to estimate the heterogeneity in cellular proliferation (FLT-PET uptake) as well the heterogeneity in marrow composition distribution (measured using whole body water-fat MRI) using positron emission tomography imaging. This will be used to design future trials as well as to determine the feasibility of PET and MRI imaging.

Source references

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-1064be0f31913988ff18
requested nct id
NCT02042924
primary nct id
NCT02042924
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Plasma+Cell+Neoplasms&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
payload sha256
390b577c8648d7ed502d939e5d7263327b73f0909e5af16d369c800271768b4f
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-1064be0f31913988ff18
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT02042924
occurrences
context exact
NCT02042924
end
11
exact text
NCT02042924
start
0
offset unit
unicode_code_points
query cond
Plasma Cell Neoplasms
query disease state id
ds-plasma-cell-neoplasms
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
source file sha256
2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
source json pointer
/studies/306/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
7ed6a0a0b39980f052e57472bcf4a5792d7877fbd449ad945ff650a4ec7e1d1a
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Plasma+Cell+Neoplasms&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice