18 and older, female only, with Cervical Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Relationship Between Copper Cu 64-ATSM Uptake in the Primary Tumor and Progression-free Survival 3 Years After ChemoradiotherapyPrimary· 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 i
Progression within 3 years
Group
Value
95% CI
64 CU-ATSM SUVmax @ Baseline
4.4
± 1.3
64 CU-ATSM T/M Ratio @ Baseline
8.2
± 4.1
No progression within 3 years
Group
Value
95% CI
64 CU-ATSM SUVmax @ Baseline
4.2
± 1.3
64 CU-ATSM T/M Ratio @ Baseline
8.0
± 3.1
Copper Cu 64-ATSM T/M Uptake and Overall SurvivalSecondary· every 3 months for first 2 years and every 6 months during year 3, up to 3 years
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.
Group
Value
95% CI
T/M Below Median
773.5
46 – 1378
T/M at or Above Median
786.0
14 – 1196
Relationship Between Copper Cu 64-ATSM Uptake and Complete Metabolic ResponseSecondary· 3 months after completion of chemoradiation
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)"
Group
Value
95% CI
Eligible Participants
23
Eligible Participants
29
Primary Tumor RecurrenceSecondary· every 3 months for first 2 years and every 6 months during year 3, up to 3 years
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
Group
Value
95% CI
T/M Below Median
773.5
46 – 1378
T/M at or Above Median
797.0
252 – 1196
Lymph Node Metastasis at BaselineSecondary· Two weeks
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
Pelvic
Group
Value
95% CI
Eligible Participants
31
Eligible Participants
27
Common Iliac
Group
Value
95% CI
Eligible Participants
14
Eligible Participants
41
Para Aortic
Group
Value
95% CI
Eligible Participants
7
Eligible Participants
48
Mediastinal
Group
Value
95% CI
Eligible Participants
0
Eligible Participants
55
Supraclavicular
Group
Value
95% CI
Eligible Participants
0
Eligible Participants
55
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 HypoxiaSecondary· baseline
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.
Group
Value
95% CI
0=<1% Tumor Cells
7.58
± 2.87
1-33% Tumor Cells
7.57
± 3.17
34-66% Tumor Cells
9.40
± 5.26
>66% Tumor Cells
7.35
± 1.20
Relationship of Copper Cu 64-ATSM Uptake T/M Ratio and CA-IX Staining Intensity Score: as a Marker of Tumor HypoxiaSecondary· baseline
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.
Group
Value
95% CI
No Staining
7.58
± 2.87
Weak Staining
6.20
± 2.56
Moderate to Strong Staining
9.40
± 4.37
Relationship of Copper Cu 64-ATSM Uptake T/M Ratio and CA-IX Composite Score as a Marker of Tumor HypoxiaSecondary· Baseline
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).
Group
Value
95% CI
Composite Score: 0
7.58
± 2.87
Composite Score: 1
5.82
± 1.99
Composite Score: 2
8.04
± 3.44
Composite Score: 3
6.50
± NA
Composite Score: 4
10.60
± 5.54
Composite Score: 6
8.20
± NA
Relationship of Copper Cu 64-ATSM Uptake T/M Ratio and VEGF Percentage of Tumor Cells Staining Score as a Marker of Tumor HypoxiaSecondary· baseline
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.
Group
Value
95% CI
0=<1% Tumor Cells
6.98
± 2.54
1-33% Tumor Cells
7.57
± 4.57
34-66% Tumor Cells
8.51
± 3.65
>66% Tumor Cells
8.44
± 4.50
Relationship of Copper Cu 64-ATSM Uptake T/M Ratio and Vascular Endothelial Growth Factor (VEGF) Staining Intensity Score: as a Marker of Tumor HypoxiaSecondary· baseline
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.
Group
Value
95% CI
No Staining
6.98
± 2.54
Weak Staining
7.50
± 3.17
Moderate to Strong Staining
10.22
± 4.93
Relationship of Copper Cu 64-ATSM Uptake T/M Ratio and Vascular Endothelial Growth Factor (VEGF) Composite Score as a Marker of Tumor HypoxiaSecondary· Baseline
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).
Group
Value
95% CI
Composite Score: 0
6.98
± 2.54
Composite Score: 1
4.44
± 1.22
Composite Score: 2
8.79
± 3.67
Composite Score: 3
6.59
± 1.83
Composite Score: 4
8.48
± 4.11
Composite Score: 6
11.76
± 6.13
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 HypoxiaSecondary· baseline
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.
Group
Value
95% CI
0=<1% Tumor Cells
9.70
± 0.42
1-33% Tumor Cells
6.01
± 1.08
34-66% Tumor Cells
8.83
± 4.22
>66% Tumor Cells
7.46
± 3.49
Sponsor's own description
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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by American College of Radiology
Last refreshed: 14 August 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00794339.