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Breast NeoplasmsBLCNCT07716644

Breast Lump Clipping Methods Comparison

A study testing Breast Lesion Clip Placement in people with Breast Neoplasms, run by University of Faisalabad at 1 site in Pakistan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Breast cancer is the most frequently diagnosed malignancy among women worldwide, with increasing rates in later life. It represents a significant healthcare challenge in low- and middle-income countries where limited access to diagnostic imaging and specialised breast services contributes to delays in diagnosis and… Read more about this study

Who is it for?
Ages 25 to 75 years
Conditions the study is for
Breast Neoplasms
What is being tested?
Breast Lesion Clip Placement
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 sitePakistan
Study dates
1 Apr 2026to 28 Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 25 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients aged 25-75 years
  • Unifocal lesion
  • Palpable T1-T4 lesion
  • Planned Neoadjuvant chemotherapy (NACT) cases
  • Patient consent for tumor localization or breast-conserving surgery (BCS)

Who cannot join

  • Known bleeding disorder
  • Inflammatory breast carcinoma
  • Multifocal or multicentric breast disease
  • Patients who do not consent for tumor localization or BCS

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Tertiary Care Hospitals, Faisalabad, Pakistan

    Faisalābad, Punjab Province, 38000

Other trials in Pakistan

About this study

Official title: Ultrasound Guided Clipping Versus Blind Clipping in Low Socioeconomic Settings: A Comparative Study

Breast cancer is the most frequently diagnosed malignancy among women worldwide, with increasing rates in later life. It represents a significant healthcare challenge in low- and middle-income countries where limited access to diagnostic imaging and specialised breast services contributes to delays in diagnosis and suboptimal treatment outcomes. Accurate localisation of breast lesions is fundamental for effective breast cancer management, particularly in patients undergoing neoadjuvant chemotherapy where the primary tumour may become clinically or radiologically occult. Breast lesion clips serve as durable markers that allow precise localization for surgical excision and radiological follow-up. This study is a prospective comparative trial being conducted at MTH Faisalabad, Pakistan, to evaluate the efficacy and cost-effectiveness of ultrasound-guided clipping versus blind clipping of breast lesions in low socioeconomic settings. A total of 50 female patients aged 25-75 years with palpable, unifocal breast tumours (T1-T4) planned for neoadjuvant chemotherapy will be randomly assigned to one of two intervention groups using computer-generated randomization. Group A will receive blind clip placement using palpation without real-time imaging guidance. Immediate confirmation will be done by ultrasonography. Group B will receive ultrasound-guided clip placement. The primary outcome measures are the accuracy of clip placement defined as," clip localization within 10 millimeters of the target lesion on imaging", The total cost of the procedure, and safety outcomes including minor complications. Secondary outcomes include patient satisfaction measured using LIKERT score and the total number of hospital visits required. The study aims to provide evidence on whether blind clipping represents a viable, cost-effective alternative to ultrasound-guided clipping in resource-constrained environments where affordability and availability of trained radiologist present significant barriers to optimal breast cancer care.

Read the detailed description

This study is designed as a single-blind randomized controlled trial. Participants diagnosed with carcinoma of the breast will be recruited from the outpatient setting of MTH in Faisalabad, Pakistan. Each participant will undergo a comprehensive initial assessment, including a detailed clinical history, physical examination, and review of available imaging studies, including ultrasound and mammography reports. Following confirmation of eligibility based on the predefined inclusion and exclusion criteria, participants will be provided with detailed information about the study objectives, procedures, potential risks and benefits, and their rights as research participants. Written informed consent will be obtained from all participants prior to enrollment.

Eligible participants will be randomly assigned to one of two intervention groups using a computer-generated randomization sequence with a 1:1 allocation ratio. The randomization sequence will be generated by an independent statistician not involved in the clinical management of participants. Group allocation will be concealed in sequentially numbered, opaque, sealed envelopes that will be opened immediately before the clipping procedure.

Group A will undergo blind clip placement. In this group, the clinician will have access to the patient's ultrasound and mammography reports to assess tumor location prior to the procedure. The clip placement will be performed using palpation of the breast lesion to guide the introducer needle. The clinician will rely on tactile feedback and surface marking to position the clip.

No real-time imaging guidance will be used during the procedure. Ultrasonography will be performed to confirm clip placement after the procedure.

Group B will undergo ultrasound-guided clip placement. In this group, the clip placement will be performed under real-time ultrasound guidance by a trained radiologist or breast surgeon. The ultrasound probe will be used to visualize the lesion continuously throughout the procedure, allowing for precise positioning of the introducer needle. The clip position will be documented with post-procedure imaging.

Measures will be taken to ensure blinding and minimize bias. Participants will be blinded to their group assignment. The nature of the procedure may make complete blinding challenging for the clinicians performing the procedure.

The intervention will be performed over a defined period within routine clinical practice. Both groups will receive standard baseline care to ensure consistency. The protocol has been designed to be feasible within routine clinical practice and reproducible in similar healthcare settings with limited resources.

Outcome assessments will be conducted after the procedure. The primary efficacy outcome will be assessed after the procedure in the ultrasound room, with pre-planned collaboration with a sonologist. The cost of the clipping procedure will be calculated based on the materials used, imaging services utilized, and personnel time. Safety outcomes will be monitored throughout the study period and documented at each clinical encounter.

Patient satisfaction will be measured using a Likert scale administered through a structured questionnaire at the time of follow-up. Participants will be asked to rate their satisfaction with various aspects of the clipping procedure, including comfort, information provided, and overall experience. The number of hospital visits will be recorded for each participant from the date of enrollment through the completion of the procedure.

Statistical analysis will be performed using SPSS version 27 statistical software. Data distribution will be assessed for normality using the Shapiro-Wilk test. Normally distributed continuous variables will be presented as means with standard deviations and compared between groups using the independent-samples t-test. Non-normally distributed variables will be presented as medians with interquartile ranges and compared using the Mann-Whitney U test. Categorical variables will be presented as frequencies and percentages and compared using the chi-square test or Fisher's exact test, as appropriate. Within-group changes over time will be evaluated using the paired t-test or Wilcoxon signed-rank test, as appropriate. A threshold for statistical significance will be established at p < 0.05.

All analyses will be performed on an intention-to-treat basis. A per-protocol analysis will also be conducted as a sensitivity analysis. Missing data will be handled using appropriate imputation methods. The results of this study will be reported in accordance with the Consolidated Standards of Reporting Trials guidelines.

This study aims to contribute to the existing body of evidence by providing controlled clinical data on the role of blind clipping in low socioeconomic settings. Furthermore, the study may serve as a basis for future research exploring optimized protocols in larger multicenter trials, potentially leading to improved breast cancer outcomes in resource-limited settings through more accessible and cost-effective localization techniques.

Being tested
Breast Lesion Clip Placement
Keywords
Low socioeconomic setting, Breast lump, Clipping, Comparative study, Ultrasound guided, Blind clipping
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Breast Lesion Clip PlacementProcedure or surgery

    The procedure involves placing a small, permanent clip marker into a breast lesion to localize it for surgical excision and radiological follow-up. In the ultrasound-guided arm, a radiologist or breast surgeon will use a sterile ultrasound probe to visualize the lesion and will deploy the clip using a specialized introducer needle. In the blind clipping arm, the clinician will rely on the palpable nature of the tumor and anatomical landmarks to guide the introducer needle and deploy the clip. The procedure takes approximately 15-30 minutes to complete, and patients are monitored for a short period afterwards for any immediate complications.

Study groups in NCT07716644
Study groupRoleWhat they receive
Blind Clip PlacementExperimentalParticipants assigned to this arm will undergo clip placement performed using palpation and anatomical landmarks without the use of real-time imaging guidance. The clinician will have access to the patient's ultrasound and mammography reports prior to the procedure to assess tumour location. The clip will be deployed using an introducer needle guided by tactile feedback and surface markings. No immediate post-procedure imaging confirmation will be obtained.
Receives: Procedure: Breast Lesion Clip Placement
Image-Guided Clip PlacementActive comparatorParticipants assigned to this arm will undergo clip placement performed under real-time ultrasound guidance with immediate confirmation of clip position. A trained radiologist or breast surgeon will use a sterile ultrasound probe to visualize the lesion continuously throughout the procedure. The introducer needle will be guided under direct visualization, and clip position will be confirmed with post-procedure imaging before the patient leaves the procedure room.
Receives: Procedure: Breast Lesion Clip Placement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of Clip Placement

    Efficacy is defined as the clip being localized in the centre of the tumour or within 10 millimetres of the target lesion on follow-up imaging. The accuracy of clip placement will be assessed by comparing the position of the clip on follow-up imaging (ultrasound or mammography) with the original tumour location as documented on pre-procedure imaging. The distance between the clip and the tumour centre will be measured in millimetres using standardized measurement techniques. Clips localized within the tumour centre or within 10 millimetres of the target lesion will be considered efficacious.

    Measured: At follow-up imaging performed 2-4 weeks after the clipping procedure

  2. Cost of Clipping

    The total cost of the clipping procedure calculated in Pakistani Rupees (PKR) including materials (clip device, introducer needle, sterile supplies), imaging services (ultrasound or mammography, if applicable), and personnel time (clinician time, nursing time, support staff time). The cost will be calculated from a healthcare provider perspective. For the ultrasound-guided arm, costs will include the ultrasound machine usage, sonographer time, and radiologist interpretation. For the blind clipping arm, costs will include the reduced imaging requirements. All costs will be recorded prospectively using standardized cost collection forms.

    Measured: At the time of the procedure and at the time of discharge

  3. Safety of the Procedure

    Safety will be assessed by monitoring for minor complications including transient pain at the clip insertion site, small haematomas, infection, clip migration, and any other adverse events. All adverse events will be recorded prospectively using standardized case report forms. Pain will be assessed using a visual analogue scale from 0 (no pain) to 10 (worst possible pain) at the time of the procedure and at follow-up. Haematoma size will be measured using ultrasound if clinically significant. Participants will be followed for any complications throughout the study period. All adverse events will be graded using a standardized severity scale (mild, moderate, severe).

    Measured: From the time of procedure through the completion of follow-up at 4 weeks post-procedure

Secondary outcomes (2)
  1. Patient Satisfaction

    Patient satisfaction with the clipping procedure will be measured using a validated LIKERT scale questionnaire administered to participants at the time of follow-up. The questionnaire assesses satisfaction with various aspects of the procedure including comfort during the procedure, adequacy of information provided prior to the procedure, overall experience with the procedure, and willingness to undergo the same procedure again if needed. Responses are recorded on a 5-point LIKERT scale ranging from 1 (very dissatisfied) to 5 (very satisfied). The total satisfaction score will be calculated by summing individual item scores, with higher scores indicating greater satisfaction.

    Measured: At the time of follow-up imaging performed 2-4 weeks after the clipping procedure

  2. Number of Hospital Visits

    The total number of hospital visits related to the clipping procedure and its follow-up will be recorded for each participant. This includes the initial consultation visit, the procedure visit, any additional visits for imaging, and any unscheduled visits for complications or other concerns. The number of visits will be counted from the date of enrollment through the completion of follow-up. This outcome assesses the healthcare utilization burden associated with each clipping method

    Measured: From the date of enrollment through the completion of follow-up at 4 weeks post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2026
  2. Study start1 Apr 2026
  3. Primary completion30 Jun 2026
  4. Study completion28 Jul 2026 (estimated)

Resources

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 N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07716644
Sponsor's protocol ID
Faiqa/TUF/EIRB/176/26
Acronym
BLC
Status last verified
Jul 2026
First submitted
16 Jul 2026
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Breast Lesion Clip Placement in people with Breast Neoplasms, run by University of Faisalabad at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Efficacy of Clip Placement (time frame: At follow-up imaging performed 2-4 weeks after the clipping procedure). The study lists 3 primary outcomes in all. 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 21 Jul 2026.

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