Cervical CancerPhase 2ACRIN6682NCT00794339
Phase II Trial of 64Cu-ATSM PET/CT in Cervical Cancer
A Phase 2 study testing 64Cu-ATSM and FDG in people with Cervical Cancer, run by American College of Radiology at 2 sites in United States.
Trial summary
RATIONALE: Diagnostic procedures, such as 64Cu-labeled diacetyl-bis[N4-methylthiosemicarbazone] (copper Cu 64-ATSM) PET/CT scans, may help doctors predict how patients will respond to treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- 64Cu-ATSM and FDG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Jul 2009to 31 Dec 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed primary invasive cervical squamous cell carcinoma
- Newly diagnosed disease
- Stage IB2 - IVA disease based on FIGO staging system
- Plan to receive standard of care treatment with concurrent cisplatin and radiation therapy (external beam and brachytherapy) per NCCN guidelines
- Must be scheduled to receive 6 weekly courses of cisplatin
- Meets 1 of the following criteria:
- Pelvic nodal (or no nodal) disease only by FDG-PET/CT scan within 4 weeks of enrollment
- Para-aortic nodal metastasis by FDG-PET/CT scan within 4 weeks of enrollment, and patient will undergo radiotherapy to para-aortic nodes
- FDG-PET/CT scan at baseline if not meeting any of the above criteria
- No stage IVB disease (distant metastases or supraclavicular metastasis) confirmed by FDG-PET/CT scan
- No recurrent invasive carcinoma of the uterine cervix regardless of previous treatment
- No know metastases to lungs, supraclavicular lymph nodes, or other organs outside of the pelvis or abdominal lymph nodes at time of diagnosis
PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to lie flat for the duration of the PET/CT scan
- No septicemia or severe infection
- No uncontrolled or poorly controlled diabetes
- No circumstances that would prevent completion of imaging studies or required clinical follow-up
- No other prior or concurrent invasive malignancies, with the exception of non-melanoma skin cancer, within the past 5 years
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior pelvic or abdominal lymphadenectomy
- No prior pelvic radiation therapy
- No previous cancer treatment contraindicates this protocol therapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90089-9181
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, 63110
About this study
Official title: Copper Cu 64-ATSM and PET/CT Scan in Predicting Disease Progression in Patients With Newly-Diagnosed Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer Who Are Undergoing Chemoradiotherapy Per NCCN Guidelines
RATIONALE: Diagnostic procedures, such as 64Cu-labeled diacetyl-bis[N4-methylthiosemicarbazone] (copper Cu 64-ATSM) PET/CT scans, may help doctors predict how patients will respond to treatment.
PURPOSE: This phase II trial is studying how well copper Cu 64-ATSM PET/CT scans work in predicting disease progression in patients undergoing standard of care treatment with cisplatin and radiation therapy (external beam and brachytherapy) per National Comprehensive Cancer Network (NCCN) guidelines for newly-diagnosed stage IB, stage II, stage III, or stage IVA cervical cancer via the Federation of Gynecology and Obstetrics (FIGO) staging systems.
Read the detailed description
OBJECTIVES:
Primary
- To define the role of pre-therapy ^64Cu-labeled diacetyl-bis(N4-methylthiosemicarbazone) (copper Cu 64-ATSM) in predicting prognosis and determining the behavior of an invasive squamous cell cervical cancer in patients with newly-diagnosed stage IB2-IVA cervical squamous cell carcinoma.
- To determine whether higher copper Cu 64-ATSM uptake is associated with lower progression-free survival of these patients after chemoradiotherapy.
Secondary
- To determine if higher copper Cu 64-ATSM uptake is associated with lower overall survival of these patients.
- To determine if higher copper Cu 64-ATSM uptake is associated with earlier primary cervical tumor recurrence and a higher rate of development of distant metastatic disease in these patients.
- To determine if higher copper Cu 64-ATSM uptake is associated with a lower frequency of complete metabolic response on 2-Deoxy-2-[18F]fluoroglucose (FDG) -PET/CT scan performed 3 months after completion of radiotherapy and chemotherapy.
- To estimate the accuracy of copper Cu 64-ATSM uptake as a predictor of progression-free survival, overall survival, primary tumor recurrence, and future development of distant metastatic disease in these patients.
- To evaluate the performance of copper Cu 64-ATSM uptake as a predictor of lymph node metastasis at study entry.
- To evaluate whether copper Cu 64-ATSM uptake correlates with tumor volume at study entry.
- To examine the relationship between tumor uptake of copper Cu 64-ATSM and other markers of tumor hypoxia, including Vascular endothelial growth factor (VEGF) , Glucose transporter 1 (GLUT1), Carbonic anhydrase IX (CA9/CA IX), and Osteopontin (OPN).
- To compare the predictive ability of pre-therapy copper Cu 64-ATSM-PET to that of post-therapy FDG-PET/CT scan.
- To assess whether pre-therapy FDG-PET/CT findings are predictive of progression-free survival.
OUTLINE: This is a multicenter study.
Patients receive copper Cu 64-ATSM IV and undergo PET/CT scan over 30 minutes 30-40 minutes later. Within 4 weeks after copper Cu 64-ATSM-PET/CT scan, patients begin planned concurrent standard of care chemoradiotherapy comprising 6 weeks of radiotherapy (external beam and brachytherapy)and weekly cisplatin administration per NCCN guidelines. Patients then undergo FDG-PET/CT scan 3 months after completion of chemoradiotherapy.
Tissue samples from previously collected cervical biopsy (obtained for diagnosis) are used for detecting hypoxic markers by immunohistochemistry analysis.
After completion of study intervention, patients are followed for every 3 months for 2 years and then every 6 months for 1 year.
- Conditions
- Cervical Cancer
- Being tested
- 64Cu-ATSM, FDG
- Keywords
- cervical squamous cell carcinoma, stage IIB cervical cancer, stage III cervical cancer, stage IV cervical cancer, stage IVA cervical cancer, stage IB cervical cancer, stage IIA cervical cancer
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
64Cu-ATSMDrug
Also called copper 64, 64Cu Diacetyl-bis(N4-methylthiosemicarbazone)
FDGDrug
Also called fludeoxyglucose F 18, Fluorodeoxyglucose (18F), 18F-FDG, 18F-fluorodeoxyglucose
| Study group | Role | What they receive |
|---|---|---|
| Copper ATSM | Experimental | pre-therapy pelvic 64Cu-ATSM-PET/CT with Pre- and post- therapy FDG PET/CT Receives: Drug: 64Cu-ATSM; Drug: FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship Between Copper Cu 64-ATSM Uptake in the Primary Tumor and Progression-free Survival 3 Years After Chemoradiotherapy
Progression-free survival (PFS) evaluated every 3 months for first 2 years and every 6 months during year 3 to determine PFS at 3years.
Cu64-ATSM Uptake measured within 14 days of baseline Uptake is a measure of activity within a tumor
- the maximum standardized uptake value (SUVmax = tracer uptake in ROI / (injected activity / patient weight))
- Tumor-to-Muscle uptake ratio (T/M, An FDG-PET/CT-guided circular region of interest of 1.0-1.5 cm in diameter is drawn around the most intense region of the primary tumor to calculate the maximum uptake within the region. In addition, regions of interest are drawn on bilateral gluteal muscle groups on at least 3 slices, and the mean uptake is calculated. The T/M is the ratio of these measurements.)
Measured: every 3 months for first 2 years and every 6 months during year 3, up to 3 years
Secondary outcomes (14)
Copper Cu 64-ATSM T/M Uptake and Overall Survival
To determine if higher 64Cu-ATSM uptake on PET/CT is associated with lower Overall survival (OS) T/M Uptake measured within 14 days of baseline;
Overall survival (OS) is measured every 3 months for first 2 years and every 6 months during year 3,until time of death or 3 years from baseline.
Measured: every 3 months for first 2 years and every 6 months during year 3, up to 3 years
Relationship Between Copper Cu 64-ATSM Uptake and Complete Metabolic Response
Complete metabolic response determined by FDG PET/CT performed 3 months after completion of chemoradiation By definition, metabolic response (as defined by NCI Concept ID: C3897320. https://www.ncbi.nlm.nih.gov/medgen/856914) is "the disappearance of metabolic tumor activity in target and non-target lesions, marked by a decrease in tumor standardized uptake value to the level of surrounding normal tissue (tumor uptake/normal uptake = ~1)"
Measured: 3 months after completion of chemoradiation
Primary Tumor Recurrence
To determine if higher 64Cu ATSM uptake is associated with earlier primary cervical tumor recurrence images were taken every 3 months for first 2 years and every 6 months during year 3, up to 3 years and evaluated for primary cervical tumor recurrence
Measured: every 3 months for first 2 years and every 6 months during year 3, up to 3 years
Lymph Node Metastasis at Baseline
Lymph nodes were evaluated at 5 locations: Pelvic, Common Iliac, Para Aortic, Mediastinal, and Supraclavicular
This outcome looks at the Association of Ratio of Tissue to Muscle (T/M) uptake with Lymph Node Metastases at Baseline
Measured: Two weeks
Relationship of Copper Cu 64-ATSM Uptake T/M Ratio and Carbonic Anhydrase IX (CA-IX) Percentage of Tumor Cells Staining Score as a Marker of Tumor Hypoxia
The Ratio of Tissue to Muscle (T/M) agent uptake measured at baseline was used as a predictor of Hypoxia Tumor Hypoxia was assessed with Carbonic anhydrase IX (CA-IX) markers using the
Percentage of Tumor Cells Staining Score:
0=<1% tumor cells; 1=1 33% tumor cells; 2=34 66% tumor cells; and 3=>66% tumor cells.
Measured: baseline
Relationship of Copper Cu 64-ATSM Uptake T/M Ratio and CA-IX Staining Intensity Score: as a Marker of Tumor Hypoxia
The Ratio of Tissue to Muscle (T/M) agent uptake measured at baseline was used as a predictor of Hypoxia Tumor Hypoxia was assessed with CA-IX markers using the
Staining Intensity Score:
0=No staining; 1=Weak staining; and 2=Moderate to strong staining.
Measured: baseline
Relationship of Copper Cu 64-ATSM Uptake T/M Ratio and CA-IX Composite Score as a Marker of Tumor Hypoxia
The Ratio of Tissue to Muscle (T/M) agent uptake measured at baseline was used as a predictor of Hypoxia Tumor Hypoxia was assessed with CA-IX markers using the
Composite Score (range 0-6):
Computed by using the coded values of Percentage of Tumor Cells Staining Score (0-3) multiplied by the coded value of Staining Intensity Score (0-2).
Measured: Baseline
Relationship of Copper Cu 64-ATSM Uptake T/M Ratio and VEGF Percentage of Tumor Cells Staining Score as a Marker of Tumor Hypoxia
The Ratio of Tissue to Muscle (T/M) agent uptake measured at baseline was used as a predictor of Hypoxia Tumor Hypoxia was assessed with VEGF markers using the
Percentage of Tumor Cells Staining Score:
0=<1% tumor cells; 1=1 33% tumor cells; 2=34 66% tumor cells; and 3=>66% tumor cells.
Measured: baseline
Relationship of Copper Cu 64-ATSM Uptake T/M Ratio and Vascular Endothelial Growth Factor (VEGF) Staining Intensity Score: as a Marker of Tumor Hypoxia
The Ratio of Tissue to Muscle (T/M) agent uptake measured at baseline was used as a predictor of Hypoxia Tumor Hypoxia was assessed with Vascular endothelial growth factor (VEGF) markers using the
Staining Intensity Score:
0=No staining; 1=Weak staining; and 2=Moderate to strong staining.
Measured: baseline
Relationship of Copper Cu 64-ATSM Uptake T/M Ratio and Vascular Endothelial Growth Factor (VEGF) Composite Score as a Marker of Tumor Hypoxia
The Ratio of Tissue to Muscle (T/M) agent uptake measured at baseline was used as a predictor of Hypoxia Tumor Hypoxia was assessed with Vascular endothelial growth factor (VEGF) markers using the
Composite Score (range 0-6):
Computed by using the coded values of Percentage of Tumor Cells Staining Score (0-3) multiplied by the coded value of Staining Intensity Score (0-2).
Measured: Baseline
Relationship of Copper Cu 64-ATSM Uptake T/M Ratio and Glucose Transporter 1 (GLUT1) Percentage of Tumor Cells Staining Score as a Marker of Tumor Hypoxia
The Ratio of Tissue to Muscle (T/M) agent uptake measured at baseline was used as a predictor of Hypoxia Tumor Hypoxia was assessed with Glucose transporter 1 (GLUT1) markers using the
Percentage of Tumor Cells Staining Score:
0=<1% tumor cells; 1=1 33% tumor cells; 2=34 66% tumor cells; and 3=>66% tumor cells.
Measured: baseline
Relationship of Copper Cu 64-ATSM Uptake T/M Ratio and Glucose Transporter 1 (GLUT1) Staining Intensity Score: as a Marker of Tumor Hypoxia
The Ratio of Tissue to Muscle (T/M) agent uptake measured at baseline was used as a predictor of Hypoxia Tumor Hypoxia was assessed with GLUT-1 markers using the
Staining Intensity Score:
0=No staining; 1=Weak staining; and 2=Moderate to strong staining.
Measured: baseline
Relationship of Copper Cu 64-ATSM Uptake T/M Ratio and Glucose Transporter 1 (GLUT1) Composite Score as a Marker of Tumor Hypoxia
The Ratio of Tissue to Muscle (T/M) agent uptake measured at baseline was used as a predictor of Hypoxia Tumor Hypoxia was assessed with Glucose transporter 1 (GLUT1) markers using the
Composite Score (range 0-6):
Computed by using the coded values of Percentage of Tumor Cells Staining Score (0-3) multiplied by the coded value of Staining Intensity Score (0-2).
Measured: Baseline
Relationship Between Copper Cu 64-ATSM Uptake and Development of Distant Metastasis
Existence of distant metastasis was evaluated every 3 months for first 2 years and every 6 months during year 3 Copper Cu 64-ATSM Uptake (T/M) measured within 14 days of baseline;
Measured: every 3 months for first 2 years and every 6 months during year 3, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2008 (estimated)
- Study start29 Jul 2009
- Primary completion31 Dec 2011
- Study completion31 Dec 2011
Why it stopped: transfer of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- American College of Radiology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), American College of Radiology Imaging Network
- Responsible party
- Sponsor
- Investigators
- Farrokh Dehdashti, MD, Principal investigator, Mallinckrodt Institute of Radiology at Washington University Medical CenterDavid A. Mankoff, MD, PhD, Study chair, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00794339
- Sponsor's protocol ID
- CDR0000624407
- Other IDs
- ACRIN-6682, U01CA080098, U01CA079778
- Acronym
- ACRIN6682
- Status last verified
- Aug 2023
- First submitted
- 19 Nov 2008
- Last updated
- 14 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: See NCI data Sharing Policy
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Copper Cu 64-ATSM and PET/CT Scan in Predicting Disease Progression in Patients With Newly-Diagnosed Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer Who Are Undergoing Chemoradiotherapy Per NCCN Guidelines
- ClinicalTrials.gov ID
- NCT00794339
- Acronym / sponsor ID
- ACRIN6682 / CDR0000624407
- Conditions
- Cervical Cancer
- Keywords
- cervical squamous cell carcinoma, stage IIB cervical cancer, stage III cervical cancer, stage IV cervical cancer, stage IVA cervical cancer, stage IB cervical cancer, stage IIA cervical cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: transfer of funding
- Enrolment
- 73 participants (actual)
- Lead sponsor
- American College of RadiologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), American College of Radiology Imaging Network
- Study start
- 29 Jul 2009 (actual)
- Primary completion
- 31 Dec 2011 (actual)
- Study completion
- 31 Dec 2011 (actual)
- First posted
- 20 Nov 2008 (estimated)
- Results
- Posted 28 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Diagnostic procedures, such as 64Cu-labeled diacetyl-bis[N4-methylthiosemicarbazone] (copper Cu 64-ATSM) PET/CT scans, may help doctors predict how patients will respond to treatment.
PURPOSE: This phase II trial is studying how well copper Cu 64-ATSM PET/CT scans work in predicting disease progression in patients undergoing standard of care treatment with cisplatin and radiation therapy (external beam and brachytherapy) per National Comprehensive Cancer Network (NCCN) guidelines for newly-diagnosed stage IB, stage II, stage III, or stage IVA cervical cancer via the Federation of Gynecology and Obstetrics (FIGO) staging systems.
Detailed description
OBJECTIVES:
Primary
- To define the role of pre-therapy ^64Cu-labeled diacetyl-bis(N4-methylthiosemicarbazone) (copper Cu 64-ATSM) in predicting prognosis and determining the behavior of an invasive squamous cell cervical cancer in patients with newly-diagnosed stage IB2-IVA cervical squamous cell carcinoma.
- To determine whether higher copper Cu 64-ATSM uptake is associated with lower progression-free survival of these patients after chemoradiotherapy.
Secondary
- To determine if higher copper Cu 64-ATSM uptake is associated with lower overall survival of these patients.
- To determine if higher copper Cu 64-ATSM uptake is associated with earlier primary cervical tumor recurrence and a higher rate of development of distant metastatic disease in these patients.
- To determine if higher copper Cu 64-ATSM uptake is associated with a lower frequency of complete metabolic response on 2-Deoxy-2-[18F]fluoroglucose (FDG) -PET/CT scan performed 3 months after completion of radiotherapy and chemotherapy.
- To estimate the accuracy of copper Cu 64-ATSM uptake as a predictor of progression-free survival, overall survival, primary tumor recurrence, and future development of distant metastatic disease in these patients.
- To evaluate the performance of copper Cu 64-ATSM uptake as a predictor of lymph node metastasis at study entry.
- To evaluate whether copper Cu 64-ATSM uptake correlates with tumor volume at study entry.
- To examine the relationship between tumor uptake of copper Cu 64-ATSM and other markers of tumor hypoxia, including Vascular endothelial growth factor (VEGF) , Glucose transporter 1 (GLUT1), Carbonic anhydrase IX (CA9/CA IX), and Osteopontin (OPN).
- To compare the predictive ability of pre-therapy copper Cu 64-ATSM-PET to that of post-therapy FDG-PET/CT scan.
- To assess whether pre-therapy FDG-PET/CT findings are predictive of progression-free survival.
OUTLINE: This is a multicenter study.
Patients receive copper Cu 64-ATSM IV and undergo PET/CT scan over 30 minutes 30-40 minutes later. Within 4 weeks after copper Cu 64-ATSM-PET/CT scan, patients begin planned concurrent standard of care chemoradiotherapy comprising 6 weeks of radiotherapy (external beam and brachytherapy)and weekly cisplatin administration per NCCN guidelines. Patients then undergo FDG-PET/CT scan 3 months after completion of chemoradiotherapy.
Tissue samples from previously collected cervical biopsy (obtained for diagnosis) are used for detecting hypoxic markers by immunohistochemistry analysis.
After completion of study intervention, patients are followed for every 3 months for 2 years and then every 6 months for 1 year.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Copper ATSM | Experimental | Drug: 64Cu-ATSM, Drug: FDGpre-therapy pelvic 64Cu-ATSM-PET/CT with Pre- and post- therapy FDG PET/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 64Cu-ATSMAlso: copper 64, 64Cu Diacetyl-bis(N4-methylthiosemicarbazone) | Drug | Copper ATSM |
| FDGAlso: fludeoxyglucose F 18, Fluorodeoxyglucose (18F), 18F-FDG, 18F-fluorodeoxyglucose | Drug | Copper ATSM |
Primary outcome
Relationship Between Copper Cu 64-ATSM Uptake in the Primary Tumor and Progression-free Survival 3 Years After Chemoradiotherapy
Time frame: every 3 months for first 2 years and every 6 months during year 3, up to 3 years
Progression-free survival (PFS) evaluated every 3 months for first 2 years and every 6 months during year 3 to determine PFS at 3years. Cu64-ATSM Uptake measured within 14 days of baseline Uptake is a measure of activity within a tumor 1. the maximum standardized uptake value (SUVmax = tracer uptake in ROI / (injected activity / patient weight)) 2. Tumor-to-Muscle uptake ratio (T/M, An FDG-PET/CT-guided circular region of interest of 1.0-1.5 cm in diameter is drawn around the most intense region of the primary tumor to calculate the maximum uptake within the region. In addition, regions of interest are drawn on bilateral gluteal muscle groups on at least 3 slices, and the mean uptake is calculated. The T/M is the ratio of these measurements.)
14 secondary outcomes
Copper Cu 64-ATSM T/M Uptake and Overall Survival
Time frame: every 3 months for first 2 years and every 6 months during year 3, up to 3 years
Relationship Between Copper Cu 64-ATSM Uptake and Complete Metabolic Response
Time frame: 3 months after completion of chemoradiation
Primary Tumor Recurrence
Time frame: every 3 months for first 2 years and every 6 months during year 3, up to 3 years
Lymph Node Metastasis at Baseline
Time frame: Two weeks
Relationship of Copper Cu 64-ATSM Uptake T/M Ratio and Carbonic Anhydrase IX (CA-IX) Percentage of Tumor Cells Staining Score as a Marker of Tumor Hypoxia
Time frame: baseline
Relationship of Copper Cu 64-ATSM Uptake T/M Ratio and CA-IX Staining Intensity Score: as a Marker of Tumor Hypoxia
Time frame: baseline
Relationship of Copper Cu 64-ATSM Uptake T/M Ratio and CA-IX Composite Score as a Marker of Tumor Hypoxia
Time frame: Baseline
Relationship of Copper Cu 64-ATSM Uptake T/M Ratio and VEGF Percentage of Tumor Cells Staining Score as a Marker of Tumor Hypoxia
Time frame: baseline
Relationship of Copper Cu 64-ATSM Uptake T/M Ratio and Vascular Endothelial Growth Factor (VEGF) Staining Intensity Score: as a Marker of Tumor Hypoxia
Time frame: baseline
Relationship of Copper Cu 64-ATSM Uptake T/M Ratio and Vascular Endothelial Growth Factor (VEGF) Composite Score as a Marker of Tumor Hypoxia
Time frame: Baseline
Relationship of Copper Cu 64-ATSM Uptake T/M Ratio and Glucose Transporter 1 (GLUT1) Percentage of Tumor Cells Staining Score as a Marker of Tumor Hypoxia
Time frame: baseline
Relationship of Copper Cu 64-ATSM Uptake T/M Ratio and Glucose Transporter 1 (GLUT1) Staining Intensity Score: as a Marker of Tumor Hypoxia
Time frame: baseline
Relationship of Copper Cu 64-ATSM Uptake T/M Ratio and Glucose Transporter 1 (GLUT1) Composite Score as a Marker of Tumor Hypoxia
Time frame: Baseline
Relationship Between Copper Cu 64-ATSM Uptake and Development of Distant Metastasis
Time frame: every 3 months for first 2 years and every 6 months during year 3, up to 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- National Cancer Institute's Clinical trial databaseLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. See NCI data Sharing Policy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farrokh Dehdashti, MD principal investigator
Mallinckrodt Institute of Radiology at Washington University Medical Center
David A. Mankoff, MD, PhD study chair
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 64Cu-ATSM and FDG in people with Cervical Cancer, run by American College of Radiology at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship Between Copper Cu 64-ATSM Uptake in the Primary Tumor and Progression-free Survival 3 Years After Chemoradiotherapy (time frame: every 3 months for first 2 years and every 6 months during year 3, up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.