TerminatedPhase 4

Anderson Circulating Tumor Cell Burden (CTCB) Study

Stopped: Terminated by sponsor.

United States3 participantsStarted 2008-12

Plain-language summary

Phase 1 - Optimization Phase: Primary Objective: The primary objective of Phase 1 of this study is to determine the time point at which maximal Circulating Tumor Cell Burden (CTCB) occurs following standard vertebroplasty and Kyphoplasty procedures relative to baseline CTCB. Phase 2 - Comparison Phase: Primary Objective: The primary objective of Phase 2 of this study is to determine the change in CTCB from baseline to post-treatment as measured using the CellSearch™ Assay and to compare the average change between treatment groups with and without the use of the Cavity SpineWand. Secondary Objectives: * To determine the change in self-reported pain level from baseline to post-treatment as measured using the visual analogue scale (VAS) for spine pain and to compare the average change in pain level between treatment groups. * To determine the change in pain status from baseline to post-treatment as measured using the Brief Pain Inventory (BPI) and to compare the average change in pain status between treatment groups. * To determine the change from baseline to post-treatment in the M.D. Anderson Cancer Center Symptom Inventory (MDASI) and to compare the average change between treatment groups. * To determine the change from baseline to post-treatment in time to walk a 50-foot distance and to compare the average change between treatment groups.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient is \>18 years old.
. Patient is a candidate for standard vertebroplasty or Kyphoplasty with reasonable safety, as determined by the physician performing the procedure.
. Patient is medically fit to undergo conscious sedation.
. Patient is able to understand and give consent to participation in the study.
. Patient presents with back pain \>= 50 (on a 0-100 VAS scale).
. Patient presents with a vertebral compression fracture believed to be due to malignancy.
. Patient agrees to undergo, prior to the procedure, both magnetic resonance imaging (MRI, within 45 days of the planned procedure) and computed tomography (CT, within 14 days of the procedure). If MRI is contraindicated (due to pacemakers, intracranial ferromagnetic metal, etc), imaging with a nuclear medicine bone scan could be used as an alternative. CT remains mandated as a planning modality for all cases.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Phase 1: Time to Maximal Circulating Tumor Cell Burden (CTCB)

Timeframe: Pre-procedure baseline blood draws through post surgery 24 hours followed at 7 days (+/- 2 days)

Phase 2: Change in CTCB From Baseline to Post-treatment

Timeframe: CTCB evaluation performed from baseline through surgery +24 hours to post 7 days (+/- 2 days)

Trial details

NCT IDNCT00819832

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-05

Results submitted2010-08-16

View on ClinicalTrials.gov More Cancer trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient is \>18 years old.
. Patient is a candidate for standard vertebroplasty or Kyphoplasty with reasonable safety, as determined by the physician performing the procedure.
. Patient is medically fit to undergo conscious sedation.
. Patient is able to understand and give consent to participation in the study.
. Patient presents with back pain \>= 50 (on a 0-100 VAS scale).
. Patient presents with a vertebral compression fracture believed to be due to malignancy.
. Patient agrees to undergo, prior to the procedure, both magnetic resonance imaging (MRI, within 45 days of the planned procedure) and computed tomography (CT, within 14 days of the procedure). If MRI is contraindicated (due to pacemakers, intracranial ferromagnetic metal, etc), imaging with a nuclear medicine bone scan could be used as an alternative. CT remains mandated as a planning modality for all cases.

What they're measuring

Phase 1: Time to Maximal Circulating Tumor Cell Burden (CTCB)

Timeframe: Pre-procedure baseline blood draws through post surgery 24 hours followed at 7 days (+/- 2 days)

Phase 2: Change in CTCB From Baseline to Post-treatment

Timeframe: CTCB evaluation performed from baseline through surgery +24 hours to post 7 days (+/- 2 days)

Anderson Circulating Tumor Cell Burden (CTCB) Study

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Anderson Circulating Tumor Cell Burden (CTCB) Study

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria